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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06953583
Registration number
NCT06953583
Ethics application status
Date submitted
11/04/2025
Date registered
1/05/2025
Date last updated
14/07/2025
Titles & IDs
Public title
A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old
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Scientific title
A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled Study (Part 1) and Open-Label Extension (Part 2) to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omaveloxolone (BIIB141) in Participants With Friedreich's Ataxia Aged 2 to < 16 Years
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Secondary ID [1]
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2025-520896-13
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Secondary ID [2]
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296FA301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Friedreich Ataxia
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Condition category
Condition code
Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Neurological
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Neurodegenerative diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Omaveloxolone
Treatment: Drugs - Placebo
Experimental: Part 1 RCT: Omaveloxolone - Participants will receive a single oral dose of omaveloxolone once a day (QD) for up to 52 weeks in Part 1 of the study.
Placebo comparator: Part 1 RCT: Placebo - Participants will receive placebo, orally, QD for up to 52 weeks in Part 1 of the study.
Experimental: Part 2 OLE: Omaveloxolone - Participants who complete Part 1 of the study and are eligible will receive a single oral dose of omaveloxolone, QD for up to 104 weeks in the Part 2 OLE study.
Treatment: Drugs: Omaveloxolone
Administered as specified in the treatment arm.
Treatment: Drugs: Placebo
Administered as specified in the treatment arm.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1 RCT: Change From Baseline in Upright Stability Score (USS) Subscale E of Modified Friedreich's Ataxia Rating Scale (mFARS)
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Assessment method [1]
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The mFARS is a validated and sensitive rating scale that was developed to quantitatively assess the severity of the neurologic features of FA in adults and adolescents. Scores on the mFARS range from 0 to 93, with lower scores indicating better neurological function. The subscales of the mFARS assessment and maximum score for each subscale are: bulbar function (Subscale A; 2 assessments of speech and cough; maximum score = 5), upper limb coordination (Subscale B; 5 assessments of coordination of movement and function in arms and hands with each limb scored individually; maximum score = 36), lower limb coordination (Subscale C; 2 assessments of coordination of movement and function of lower limbs with each limb scored individually; maximum score = 16), and upright stability (USS, Subscale E; 9 assessments of sitting posture, stance, tandem walk, and gait assessments; maximum score = 36).
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Timepoint [1]
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Baseline, Week 52
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Primary outcome [2]
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Part 2 OLE: Number of Participants With Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (TESAE)
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Assessment method [2]
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Timepoint [2]
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From the first dose of the study drug in Part 2 up to the end of follow-up period in Part 2 (up to Week 105)
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Primary outcome [3]
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Part 2 OLE: Number of Participants With Change From Baseline in Cardiac Function Assessed by Echocardiogram (ECHO)
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Assessment method [3]
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Timepoint [3]
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Baseline (Week 52) up to Week 104
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Primary outcome [4]
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Part 2 OLE: Change From Baseline in Height
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Assessment method [4]
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Timepoint [4]
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Baseline (Week 52) up to Week 104
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Primary outcome [5]
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Part 2 OLE: Change From Baseline in Weight
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Assessment method [5]
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Timepoint [5]
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Baseline (Week 52) up to Week 104
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Primary outcome [6]
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Part 2 OLE: Change From Baseline in Body Mass Index (BMI)
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Assessment method [6]
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Timepoint [6]
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Baseline (Week 52) up to Week 104
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Primary outcome [7]
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Part 2 OLE: Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
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Assessment method [7]
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The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment of individuals = 6 years of age. The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered by the clinician during any evaluation or risk assessment to identify the level and type of suicidality present. The assessment includes "yes" or "no" responses for 5 questions each, related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings are provided for severity of ideation, from 1 to 5, with 5 being the most severe.
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Timepoint [7]
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Baseline (Week 52) up to Week 104
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Primary outcome [8]
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Part 2 OLE: Percentage of Participants at Each Tanner Stage
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Assessment method [8]
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Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected at baseline for all participants and will be stopped once the participant reaches Tanner Stage 5 in all gender-appropriate scales.
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Timepoint [8]
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Baseline (Week 52) up to Week 104
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Primary outcome [9]
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Part 2 OLE: Number of Participants at Each Tanner Stage
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Assessment method [9]
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Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected at baseline for all participants and will be stopped once the participant reaches Tanner Stage 5 in all gender-appropriate scales.
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Timepoint [9]
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Baseline (Week 52) up to Week 104
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Secondary outcome [1]
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Part 1 RCT: Change From Baseline in Friedreich's Ataxia-Health Index (FA-HI)
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Assessment method [1]
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The FA-HI is a participant reported survey that assesses overall disease burden on a 100-point scale, with 0 representing no disease burden and 100 representing the maximum level of disease burden containing 113 symptoms questions representing 18 symptomatic subscales.
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Timepoint [1]
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Baseline, Week 52
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Secondary outcome [2]
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Part 1 RCT: Change From Baseline in Modified Friedreich's Ataxia Rating Scale (mFARS)
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Assessment method [2]
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The mFARS is a validated and sensitive rating scale that was developed to quantitatively assess the severity of the neurologic features of FA in adults and adolescents. Scores on the mFARS range from 0 to 93, with lower scores indicating better neurological function. The subscales of the mFARS assessment and maximum score for each subscale are: bulbar function (Subscale A; 2 assessments of speech and cough; maximum score = 5), upper limb coordination (Subscale B; 5 assessments of coordination of movement and function in arms and hands with each limb scored individually; maximum score = 36), lower limb coordination (Subscale C; 2 assessments of coordination of movement and function of lower limbs with each limb scored individually; maximum score = 16), and upright stability (USS, Subscale E; 9 assessments of sitting posture, stance, tandem walk, and gait assessments; maximum score = 36).
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Timepoint [2]
0
0
Baseline, Week 52
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Secondary outcome [3]
0
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Part 1 RCT: Change From Baseline in Patient Global Impressions-Severity (PGI-S)
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Assessment method [3]
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PGI-S will be conducted for participants 7 to \< 16 years of age. These are clinically meaningful outcome measures that are participant-relevant across all age groups and disease severities for this population. PGI -S is a 1-item questionnaire where the response is recorded on a 4-point scale scored as: 1-normal, 2-mild, 3-moderate, or 4-severe.
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Timepoint [3]
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0
Baseline, Week 52
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Secondary outcome [4]
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Part 1 RCT: Change From Baseline in Clinical Global Impressions-Severity (CGI-S)
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Assessment method [4]
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The CGI-S will be conducted for all enrolled participants, 2 to \< 16 years of age. The CGI-S rating evaluates the severity of individual symptoms and treatment response in participants with mental disorders. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
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Timepoint [4]
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0
Baseline, Week 52
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Secondary outcome [5]
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Part 1 RCT: Change From Baseline in Friedreich's Ataxia-Activities of Daily Living (FA-ADL)
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Assessment method [5]
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Participants will answer the 9 questions of the FA-ADL survey in an interview style conducted by any site staff. The FA-ADL survey assesses 9 concepts: (1) speech; (2) swallowing; (3) cutting food and handling utensils; (4) dressing; (5) personal hygiene; (6) falling; (7) walking; (8) quality of sitting position; and (9) bladder function.
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Timepoint [5]
0
0
Baseline, Week 52
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Secondary outcome [6]
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Part 1 RCT: Number of Participants With Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (TESAE)
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Assessment method [6]
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Timepoint [6]
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From first dose of study drug up to end of follow up period in Part 1 RCT (up to Week 54)
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Secondary outcome [7]
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Part 1 RCT: Number of Participants With Change From Baseline in Cardiac Function Assessed by Echocardiogram (ECHO)
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Assessment method [7]
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Timepoint [7]
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Baseline, Weeks 26 and 52
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Secondary outcome [8]
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Part 1 RCT: Change From Baseline in Height
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Assessment method [8]
0
0
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Timepoint [8]
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Baseline up to Week 52
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Secondary outcome [9]
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Part 1 RCT: Change From Baseline in Weight
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Assessment method [9]
0
0
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Timepoint [9]
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Baseline up to Week 52
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Secondary outcome [10]
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Part 1 RCT: Change From Baseline in Body Mass Index (BMI)
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Assessment method [10]
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0
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Timepoint [10]
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Baseline up to Week 52
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Secondary outcome [11]
0
0
Part 1 RCT: Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)
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Assessment method [11]
0
0
The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment of individuals = 6 years of age. The C-SSRS is a clinical interview providing a summary of both ideation and behavior that can be administered by the clinician during any evaluation or risk assessment to identify the level and type of suicidality present. The assessment includes "yes" or "no" responses for 5 questions each, related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings are provided for severity of ideation, from 1 to 5, with 5 being the most severe.
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Timepoint [11]
0
0
Baseline up to week 52
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Secondary outcome [12]
0
0
Part 1 RCT: Percentage of Participants at Each Tanner Stage
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Assessment method [12]
0
0
Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected at baseline for all participants and will be stopped once the participant reaches Tanner Stage 5 in all gender-appropriate scales.
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Timepoint [12]
0
0
Screening and Week 52
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Secondary outcome [13]
0
0
Part 1 RCT: Number of Participants at Each Tanner Stage
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Assessment method [13]
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0
Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected at baseline for all participants and will be stopped once the participant reaches Tanner Stage 5 in all gender-appropriate scales.
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Timepoint [13]
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Screening and Week 52
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Secondary outcome [14]
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Part 1 RCT: Plasma Concentrations of Omaveloxolone
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Assessment method [14]
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0
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Timepoint [14]
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Pre-dose and post-dose on Day 1, Weeks 4, 12 and 26
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Secondary outcome [15]
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Part 2 OLE: Change From Baseline in Modified Friedreich's Ataxia Rating Scale (mFARS), Including Upright Stability Score (USS)
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Assessment method [15]
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0
The mFARS is a validated and sensitive rating scale that was developed to quantitatively assess the severity of the neurologic features of FA in adults and adolescents. Scores on the mFARS range from 0 to 93, with lower scores indicating better neurological function. The subscales of the mFARS assessment and maximum score for each subscale are: bulbar function (Subscale A; 2 assessments of speech and cough; maximum score = 5), upper limb coordination (Subscale B; 5 assessments of coordination of movement and function in arms and hands with each limb scored individually; maximum score = 36), lower limb coordination (Subscale C; 2 assessments of coordination of movement and function of lower limbs with each limb scored individually; maximum score = 16), and upright stability (USS, Subscale E; 9 assessments of sitting posture, stance, tandem walk, and gait assessments; maximum score = 36).
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Timepoint [15]
0
0
Baseline (Week 52) up to Week 104
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Secondary outcome [16]
0
0
Part 2 OLE: Change From Baseline in Friedreich's Ataxia-Activities of Daily Living (FA-ADL)
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Assessment method [16]
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Participants will answer the 9 questions of the FA-ADL survey in an interview style conducted by any site staff. The FA-ADL survey assesses 9 concepts: (1) speech; (2) swallowing; (3) cutting food and handling utensils; (4) dressing; (5) personal hygiene; (6) falling; (7) walking; (8) quality of sitting position; and (9) bladder function. Every participant will be instructed to answer the 9 questions. Total scores on FA-ADL will be used as a secondary endpoint to assess efficacy in participants 7 to \< 16 years of age.
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Timepoint [16]
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0
Baseline (Week 52) up to Week 104
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Secondary outcome [17]
0
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Part 2 OLE: Change From Baseline in Friedreich's Ataxia-Health Index (FA-HI)
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Assessment method [17]
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0
The FA-HI is a participant reported survey that assesses overall disease burden on a 100-point scale, with 0 representing no disease burden and 100 representing the maximum level of disease burden containing 113 symptoms questions representing 18 symptomatic subscales.
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Timepoint [17]
0
0
Baseline (Week 52) up to Week 104
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Secondary outcome [18]
0
0
Part 2 OLE: Change From Baseline in Patient Global Impressions-Severity (PGI-S)
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Assessment method [18]
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PGI-S will be conducted for participants 7 to \< 16 years of age. These are clinically meaningful outcome measures that are participant relevant across all age groups and disease severities for this population. PGI -S is a 1-item questionnaire where the response is recorded on a 4-point scale scored as: 1-normal, 2-mild, 3-moderate, or 4- severe.
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Timepoint [18]
0
0
Baseline (Week 52) up to Week 104
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Secondary outcome [19]
0
0
Part 2 OLE: Change From Baseline in Clinical Global Impressions-Severity (CGI-S)
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Assessment method [19]
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The CGI-S will be conducted for all enrolled participants, 2 to \< 16 years of age. The CGI-S rating evaluates the severity of individual symptoms and treatment response in participants with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the participant's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.
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Timepoint [19]
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Baseline (Week 52) up to Week 104
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Eligibility
Key inclusion criteria
Part 1 RCT: Key inclusion criteria:
* Diagnosed with genetically confirmed Friedreich's Ataxia (FA), i.e., homozygous for guanine-adenine-adenine (GAA) repeat expansion in intron-1 of the frataxin gene, or GAA repeat expansion in 1 allele and with point mutations or deletions, or other non-GAA expansion mutations in the other allele.
* Symptomatic for FA as reported by the participant and/or the parent/caregiver a. Children 7 to < 16 years must also have an upright stability score (USS) score of 10 to = 34 at baseline
Part 1 RCT: Key exclusion criteria:
* Glycosylated hemoglobin A1C (HbA1c) > 11%
* B-type natriuretic peptide (BNP) > 200 picograms per milliliter (pg/mL) at screening
* Ejection fraction (EF) < 40% [based on echocardiogram (ECHO) performed at screening visit]
* Clinically significant cardiac disease except mild to moderate cardiomyopathy
Part 2 OLE: Eligibility criteria:
* Participants have completed Part 1 RCT of the study and no discontinuation criteria have been met
* Safety and tolerability data from Part 1 RCT are supportive of continuation in the judgement of the investigator
1. If alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or total bilirubin (TBL) are > 2× upper limit of normal (ULN) at the previous visit assessment, Part 2 Day 1 should be delayed until ALT and AST are < 1.5× ULN and TBL is < 2× ULN
2. If BNP is > 200 pg/mL at the previous visit assessment, Part 2 Day 1 should be delayed until BNP is < 200 pg/mL
3. If any other clinically significant laboratory abnormalities are present based on the previous visit assessments, Part 2 Day 1 should be delayed until the abnormalities are resolved
4. In the event of intercurrent illness or other change in health status of the participant, additional Part 1 screening assessments may be repeated prior to initiation of Part 2, based on the judgement of the investigator in consultation with the medical monitor
Note: Other protocol-defined Inclusion/
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Minimum age
2
Years
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Maximum age
15
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/06/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/11/2029
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Actual
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Sample size
Target
255
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Murdoch Childrens Research Institute (MCRI) - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
California
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Country [2]
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0
United States of America
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State/province [2]
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Florida
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0
United States of America
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State/province [3]
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0
Pennsylvania
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Country [4]
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0
United States of America
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State/province [4]
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0
Tennessee
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Virginia
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Country [6]
0
0
Austria
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State/province [6]
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0
Innsbruck
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Country [7]
0
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Brazil
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State/province [7]
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0
Distrito Federal
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Country [8]
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Brazil
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State/province [8]
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Sao Paulo
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Country [9]
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Canada
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State/province [9]
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0
Quebec
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Country [10]
0
0
Denmark
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State/province [10]
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0
Copenhagen
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Country [11]
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France
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State/province [11]
0
0
Hérault
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Country [12]
0
0
France
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State/province [12]
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Paris
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Country [13]
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Germany
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State/province [13]
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0
Aachen
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Germany
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State/province [14]
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Giessen
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0
0
Germany
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State/province [15]
0
0
Hamburg
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Country [16]
0
0
Ireland
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State/province [16]
0
0
Dublin
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Country [17]
0
0
Italy
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State/province [17]
0
0
Lazio
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Country [18]
0
0
Italy
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State/province [18]
0
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Veneto
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Country [19]
0
0
Italy
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State/province [19]
0
0
Milano
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Country [20]
0
0
Netherlands
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State/province [20]
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0
Nijmegen
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Country [21]
0
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Spain
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State/province [21]
0
0
Espluges De Llobregat
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Country [22]
0
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Spain
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State/province [22]
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Madrid
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Country [23]
0
0
United Kingdom
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State/province [23]
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0
South Yorkshire
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Country [24]
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0
United Kingdom
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State/province [24]
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0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biogen
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
In this study, researchers will learn more about the effects and safety of BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedreich's Ataxia (FA) who are at least 16 years old. But, it is not yet available for children and teens with FA who are younger than 16 years old. The main objective of this study is to learn how BIIB141 works in the body and about its safety in children and teens who are 2 to 15 years old. The main questions researchers want to answer in this study are: * How does BIIB141 affect the participants' FA symptoms balance and stability? * How many participants have medical problems during the study? * Are there any changes in the participants' overall health during the study? * Are there any changes in the participants' heart health? * Are there any changes in how the participants move through puberty? Puberty is the time in someone's life when their body changes from a child to an adult. Researchers will also learn more about: - How the body processes BIIB141 in children and teens This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center. * There are 2 parts in this study. During Part 1, participants will take either BIIB141 or a placebo once a day. * In Part 1, participants will take BIIB141 or the placebo in a study research center on Day 1, and then at in-person visits at Week 4, Week 12, Week 26, and Week 52. On all other days, they will take BIIB141 or the placebo at home. Part 1 lasts up to 52 weeks. * During Part 2, participants from Part 1 will either continue taking BIIB141 or start it if they were taking the placebo. Part 2 will last up to 104 weeks. * In Part 1, participants will have up to 10 visits to their study research center and a phone call at Week 2. In Part 2, participants will have visits at Weeks 4, 8,12, 26, and every 26 weeks after that until they leave the study, and a phone call at Week 2. There will be a final phone call to check on the participants' health 31 days after their last dose. * Each participant will be in the study for up to about 3 years
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Trial website
https://clinicaltrials.gov/study/NCT06953583
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Medical Director
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Address
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0
Biogen
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Country
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0
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Phone
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Fax
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0
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Email
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0
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Contact person for public queries
Name
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Patient Navigator
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Address
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Country
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0
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Phone
0
0
877-223-3576
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Fax
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0
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Email
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0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06953583
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