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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05107128
Registration number
NCT05107128
Ethics application status
Date submitted
25/10/2021
Date registered
4/11/2021
Date last updated
10/12/2024
Titles & IDs
Public title
A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)
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Scientific title
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease
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Secondary ID [1]
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2021-005577-16
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Secondary ID [2]
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718-CIH-201
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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:
Huntington's Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SAGE-718
Treatment: Drugs - Placebo
Experimental: SAGE-718 - Participants will receive SAGE-718, once daily for 84 days.
Placebo comparator: Placebo - Participants will receive placebo, once daily for 84 days.
Treatment: Drugs: SAGE-718
Oral capsules.
Treatment: Drugs: Placebo
SAGE-718-matching oral capsules.
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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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Change From Baseline in the Symbol Digit Modalities Test (SDMT)
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Assessment method [1]
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SDMT test measures the number of items correctly paired out of a maximum of 110 pairs in 90 seconds. Scores may range from 0 to 110, with higher scores indicating better cognitive functioning.
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Timepoint [1]
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Baseline and Day 84
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Secondary outcome [1]
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Change From Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) - Independence Scale
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Assessment method [1]
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The UHDRS independence scale is a single item of independence rated from 10 to 100, with higher scores indicating better functioning than lower scores.
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Timepoint [1]
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Baseline and Day 84
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Secondary outcome [2]
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Change From Baseline in the Trial Making Test Part B
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Assessment method [2]
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The Trail Making test is a speeded graphomotor test of visual attention and task switching. Part B includes a set-switching component that requires participants to connect a series of alternating numbers and letters in order from lowest to highest (i.e., 1-A-2-B-3-C) in the shortest time possible. The time limit to complete the task is 240 seconds at which point the test is stopped and scored using the maximum allowable time if not yet completed. The number of errors is recorded as well. Greater time indicates greater impairment.
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Timepoint [2]
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Baseline and Day 84
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Secondary outcome [3]
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Change From Baseline in the One Touch Stockings of Cambridge (OTS-Mean Latency until Correct response)
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Assessment method [3]
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The OTS is a computerized test of executive function that measures time to correct response. Greater time indicates greater impairment.
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Timepoint [3]
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Baseline and Day 84
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Secondary outcome [4]
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Change From Baseline in the Paced Tapping Test (PTAP)
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Assessment method [4]
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The PTAP uses auditory pacing tones with participants instructed to synchronize their fingertaps to the rhythm of these tones. This is followed by a self-paced phase, where the auditory pacing cue is removed. The paced tapping consistency is calculated as 1/standard deviation (SD) of the intertap interval (1/msec). Higher scores indicate increased accuracy.
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Timepoint [4]
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Baseline and Day 84
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Secondary outcome [5]
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Change From Baseline in the Huntington's Disease Everyday Functioning (Hi-DEF) Home Subdomain Score
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Assessment method [5]
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The Hi-DEF scale is a self-reported questionnaire to capture difficulties experienced in daily life due to HD across four different areas of functioning including at home, at work, driving, and relationships. It is used to rate the functioning difficulty using a 5-point Likert scale from 1 (No Difficulty) to 5 (Cannot do this anymore) and the total score for the home subdomain will be obtained by summing the individual item scores. Lower scores indicate better daily functioning.
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Timepoint [5]
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Baseline and Day 84
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Secondary outcome [6]
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Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Cognitive Status Subdomain Score
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Assessment method [6]
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CGI-S is a scale that rates the severity of the participant's condition over the past 7 days. For this trial, CGI-S has been segmented into 4 subdomains: motor signs, motor complications, cognitive status, and disability. The responses are scored on a scale ranging from 0 (normal - no symptoms present) to 6 (severely disabled; helpless; complete assistance needed). Higher scores indicate greater disease symptom severity.
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Timepoint [6]
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Baseline and Day 84
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Secondary outcome [7]
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Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [7]
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An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is defined as an AE with onset after the start of the investigational product, or any worsening of a pre-existing medical condition/AE with onset after the start of the investigational product and throughout the study.
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Timepoint [7]
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Up to approximately 112 days
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Eligibility
Key inclusion criteria
1. Meet all the following criteria for HD at Screening (Days -28 to -2):
1. Genetically confirmed disease with huntingtin gene CAG expansion =36.
2. At screening, UHDRS-Total Functional Capacity (TFC) score >6 and <13 suggesting no more than a moderate level of functional impairment.
3. No features of juvenile HD.
2. Score of 15 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at screening indicating the presence of cognitive impairment.
3. Be willing to invite a study partner, if available, who is reliable, competent, and at least 18 years of age to participate in the study.
4. Be ambulatory (use of assistance devices such as a walker or cane is acceptable, as is occasional use of wheelchair, as judged by the investigator. Individuals requiring a wheelchair on a regular basis are excluded), able to travel to the study center, and, as judged by the investigator, is likely to be able to continue to travel to the study center to complete study visits for the duration of the study.
5. Completion of Huntington's Disease Cognitive Assessment Battery (HD-CAB) Trail Making-B Test in less than 240 seconds at Screening (Days -28 to -2).
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Minimum age
25
Years
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Maximum age
65
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
1. Have participated in a previous clinical study of SAGE-718, have previous exposure to gene therapy, have participated in any HD investigational drug, biologic, or device trial within 180 days, or a non-HD drug, biologic, or device trial within 30- days or 5-half-lives (whichever is longer).
(Note: Participants with confirmation of enrollment in the placebo arm of these trials would not be excluded.)
2. Have a diagnosis of an ongoing neurodegenerative condition other than HD, including but not limited to Alzheimer's Disease, vascular dementia, dementia with Lewy bodies, or Parkinson's Disease.
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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 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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
10/02/2022
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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
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Actual
3/10/2024
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Sample size
Target
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Accrual to date
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Final
189
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Sage Investigational Site - Westmead
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Recruitment hospital [2]
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Sage Investigational Site - Herston
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Recruitment hospital [3]
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Sage Investigational Site - Parkdale
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Recruitment hospital [4]
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Sage Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3195 - Parkdale
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arkansas
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California
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Colorado
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District of Columbia
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Florida
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Illinois
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Indiana
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Ohio
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Canada
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Nova Scotia
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Ontario
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Quebec
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London
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Aberdeen
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Birmingham
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Cardiff
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Leeds
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Newcastle Upon Tyne
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Plymouth
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United Kingdom
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sage Therapeutics
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of this study is to evaluate the effect of SAGE-718 on cognitive performance and functioning in participants with HD.
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Trial website
https://clinicaltrials.gov/study/NCT05107128
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
Name
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Grant Rutledge, PhD
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Address
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Phone
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339-368-8432
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Fax
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Email
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[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)?
No
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No/undecided IPD sharing reason/comment
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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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/NCT05107128
Download to PDF