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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04961671
Registration number
NCT04961671
Ethics application status
Date submitted
25/02/2019
Date registered
26/02/2019
Date last updated
14/02/2023
Titles & IDs
Public title
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
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Scientific title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)
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Secondary ID [1]
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2018-004337-32
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Secondary ID [2]
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3101-303-002
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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:
Urothelial Carcinoma
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Chronic Migraine
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Eligibility
Key inclusion criteria
* At least a 1-year history of chronic migraine (CM) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3), 2018
* Age of the participant at the time of migraine onset < 50 years
* Confirmation of headache/migraine headache day frequency as follows:
* History of, on average, = 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND
* >=15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
* >=8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
* Participants must be using a medically acceptable and effective method of birth control during the course of the entire study
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Minimum age
18
Years
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Maximum age
80
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
* Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
* History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
* Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 and Visit 2.
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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 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
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
11/03/2019
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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
20/01/2022
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Sample size
Target
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Accrual to date
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Final
778
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Recruitment in Australia
Recruitment state(s)
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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 evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.
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Trial website
https://clinicaltrials.gov/study/NCT04961671
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
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 are available at
https://clinicaltrials.gov/study/NCT04961671
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