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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03855137




Registration number
NCT03855137
Ethics application status
Date submitted
25/02/2019
Date registered
26/02/2019

Titles & IDs
Public title
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
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)
Secondary ID [1] 0 0
2018-004337-32
Secondary ID [2] 0 0
3101-303-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atogepant 30 mg
Treatment: Drugs - Atogepant 60 mg
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Participants received atogepant-matching placebo tablets, orally, twice daily (BID) for 12 weeks in a double-blind (DB) treatment period.

Active comparator: Atogepant 30 mg BID - Participants received atogepant 30 mg tablet, orally, BID and atogepant-matching placebo tablets orally, BID for up to 12 weeks in a DB treatment period.

Active comparator: Atogepant 60 mg QD - Participants received atogepant 60 mg, orally, once daily (QD) along with atogepant-matching placebo 30 mg as morning dose followed by atogepant-matching placebo 30 mg and 60 mg as evening doses for up to 12 weeks in a DB treatment period.


Treatment: Drugs: Atogepant 30 mg
Tablets containing 30 mg atogepant

Treatment: Drugs: Atogepant 60 mg
Tablets containing 60 mg atogepant

Treatment: Drugs: Placebo
30 mg/60 mg tablets containing atogepant-matching placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in mITT Population
Timepoint [1] 0 0
Baseline to Week 12
Primary outcome [2] 0 0
Change From Baseline in Mean Monthly Migraine Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in mITT Population
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Change From Baseline in Mean Monthly Headache Days Across 12-Week Treatment Period in Off-Treatment Hypothetical Estimand Population
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in mITT Population
Timepoint [3] 0 0
Baseline to Week 12
Secondary outcome [4] 0 0
Change From Baseline in Mean Monthly Acute Medication Use Days Across 12-Week Treatment Period in Off-treatment Hypothetical Estimand Population
Timepoint [4] 0 0
Baseline to Week 12
Secondary outcome [5] 0 0
Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in mITT Population
Timepoint [5] 0 0
Baseline to Week 12
Secondary outcome [6] 0 0
Percentage of Participants With at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days in Off-Treatment Hypothetical Estimand Population
Timepoint [6] 0 0
Baseline to Week 12
Secondary outcome [7] 0 0
Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score at Week 12 in Off-Treatment Hypothetical Estimand Population
Timepoint [7] 0 0
At Week 12
Secondary outcome [8] 0 0
Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population
Timepoint [8] 0 0
Baseline to Week 12
Secondary outcome [9] 0 0
Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D Across 12-Week Treatment Period in mITT Population
Timepoint [9] 0 0
Baseline to Week 12
Secondary outcome [10] 0 0
Change From Baseline in the Headache Impact Test (HIT-6) Total Score at Week 12 in Off-Treatment Hypothetical Estimand Population
Timepoint [10] 0 0
At Week 12

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/01/2022
Sample size
Target
Accrual to date
Final
778
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital /ID# 237008 - St Leonards
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital /ID# 236859 - Parkville
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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Arkansas
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California
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Louisiana
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Massachusetts
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Minnesota
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Mississippi
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Nevada
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New Hampshire
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New Mexico
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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China
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Guangdong
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China
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Hebei
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China
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Henan
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China
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Jilin
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China
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Zhejiang
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Suzhou
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Wuhan
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Hradec Kralove
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Kladno
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Czechia
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Ostrava
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Czechia
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Prague 10
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Czechia
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Prague 4
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Czechia
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Prague
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Czechia
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Praha
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Czechia
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Zlin
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France
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Bron
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France
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Clermont Ferrand
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Germany
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Berlin
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Germany
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Essen
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Germany
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Hamburg
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Germany
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Kassel
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Germany
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Kiel
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Germany
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München
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Italy
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Bari
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Italy
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Florence
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Milan
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Napoli
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Pavia
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Rome
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Ehime
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Tochigi
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Tokyo
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Yamanashi
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Seoul Teugbyeolsi
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Seoul
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Kujawsko-pomorskie
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Russian Federation
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Tatarstan, Respublika
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Russian Federation
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Moscow
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Spain
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A Coruna
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Spain
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Navarra
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Barcelona
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Sevilla
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Spain
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Valencia
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Spain
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Valladolid
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Spain
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Zaragoza
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Sweden
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Helsingborg
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Taiwan
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Taichung City
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Taiwan
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Taiwan
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Tainan
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Taiwan
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Taipei City
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United Kingdom
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Liverpool
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ALLERGAN INC.
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03855137