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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
Date last updated
14/02/2023

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
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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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Liverpool
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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
This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.
Trial website
https://clinicaltrials.gov/study/NCT03855137
Trial related presentations / publications
Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.
Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.
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



Summary Results

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