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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03855137
Ethics application status
Date submitted
25/02/2019
Date registered
26/02/2019
Date last updated
27/10/2020

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
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

Active Comparator: Atogepant 30 mg BID - Taken twice daily

Active Comparator: Atogepant 60 mg - Taken once daily

Placebo Comparator: Placebo - Taken twice daily


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 the treatment period - Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
Change from baseline in mean monthly headache days across the 12-week treatment period - Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.
Timepoint [1] 0 0
12 Weeks
Secondary outcome [2] 0 0
Change from baseline in mean monthly acute medication use days across the 12-week treatment period - Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.
Timepoint [2] 0 0
12 Weeks
Secondary outcome [3] 0 0
At least a 50% reduction in 3-month average of monthly migraine days - Defined as participants with at least a 50% reduction from baseline in monthly migraine days
Timepoint [3] 0 0
12 Weeks
Secondary outcome [4] 0 0
Change from baseline in MSQ v2.1 Role Function-Restrictive domain score at Week 12 - The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into 3 domains: Role Function Restrictive assesses how migraines limit one's daily social and work-related activities; Role Function Preventive assesses how migraines prevent these activities; and the Emotional Function domain assesses the emotions associated with migraines.
Timepoint [4] 0 0
12 Weeks
Secondary outcome [5] 0 0
Change from baseline in mean monthly Performance of Daily Activities domain score of the AIM-D across the 12-week treatment period. (Excluding participants from Europe & Canada) - The Activity Impairment in Migraine-Diary (AIM-D) is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items).
Timepoint [5] 0 0
12 Weeks
Secondary outcome [6] 0 0
Change from baseline in mean monthly Physical Impairment domain score of the AIM-D across the 12-week treatment period. (Excluding participants from Europe & Canada) - The Activity Impairment in Migraine-Diary (AIM-D) is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items).
Timepoint [6] 0 0
12 Weeks
Secondary outcome [7] 0 0
Change from baseline in the Headache Impact Test (HIT-6) total score at Week 12 (Participants in Europe and Canada only) - The HIT-6 is a 6-question assessment used to measure the impact headaches have on a participant's ability to function on the job, at school, at home, and in social situations. It assesses the effect that headaches have on normal daily life and the participant's ability to function.
Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses - each of which is assigned a score ranging from 6 points (never) to 13 points (always).
Timepoint [7] 0 0
12 Weeks

Eligibility
Key inclusion criteria
- At least a 1-year history of CM consistent with a diagnosis according to the 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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2065 - Parkville
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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District of Columbia
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Florida
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Georgia
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Indiana
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Kansas
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Louisiana
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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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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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China
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Hubei
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China
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China
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Shanxi
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China
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Zhejiang
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China
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China
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Guangzhou
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Czechia
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Prague
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Kladno
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Germany
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Koenigstein Im Taunus
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Kyoto
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Miyaga
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Yamanashi
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Ehime
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Stockholm
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Taichung
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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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Fazakerley
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United Kingdom
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Glasgow

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the efficacy, safety and tolerability of atogepant in participants
with chronic migraine. This study includes a 12-week treatment period.
Trial website
https://clinicaltrials.gov/show/NCT03855137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Registry Team
Address 0 0
Country 0 0
Phone 0 0
877-277-8566
Fax 0 0
Email 0 0
IR-CTRegistration@allergan.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03855137