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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04686136
Registration number
NCT04686136
Ethics application status
Date submitted
21/12/2020
Date registered
28/12/2020
Date last updated
23/03/2023
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
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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
N/A
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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
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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Type of endpoint/s
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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
13/09/2024
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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
Allergan
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Address
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Country
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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/ct2/show/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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ALLERGAN INC.
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Address
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Allergan
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04686136
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