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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04686136
Registration number
NCT04686136
Ethics application status
Date submitted
21/12/2020
Date registered
28/12/2020
Date last updated
17/04/2024
Titles & IDs
Public title
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
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Scientific title
A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine
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Secondary ID [1]
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2020-002470-27
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Secondary ID [2]
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3101-312-002
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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:
Episodic Migraine
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Chronic Migraine
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atogepant 60 mg
Experimental: Atogepant 60 mg - Taken once daily
Treatment: Drugs: Atogepant 60 mg
Tablets containing 60 mg of Atogepant
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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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Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
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Assessment method [1]
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Timepoint [1]
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156 weeks
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Secondary outcome [1]
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Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
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Assessment method [1]
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Timepoint [1]
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156 weeks
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Secondary outcome [2]
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Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
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Assessment method [2]
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Timepoint [2]
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156 weeks
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Secondary outcome [3]
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Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
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Assessment method [3]
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Timepoint [3]
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156 weeks
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Secondary outcome [4]
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Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
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Assessment method [4]
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A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior)
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Timepoint [4]
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156 weeks
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Eligibility
Key inclusion criteria
- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.
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Minimum age
18
Years
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Maximum age
80
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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
* Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
* Participants with an ECG indicating clinically significant abnormalities at Visit 1.
* Participants with hypertension at Visit 1.
* Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
19/02/2021
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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
8/10/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
596
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Recruitment in Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine
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Trial website
https://clinicaltrials.gov/study/NCT04686136
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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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?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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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/ourmember/abbvie/
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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/NCT04686136
Download to PDF