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Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855137
Recruitment Status : Completed
First Posted : February 26, 2019
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: Atogepant 30 mg Drug: Atogepant 60 mg Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : January 20, 2022
Actual Study Completion Date : January 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Atogepant 30 mg BID
Taken twice daily
 Drug: Atogepant 30 mg
Tablets containing 30 mg atogepant
Active Comparator: Atogepant 60 mg
Taken once daily
 Drug: Atogepant 60 mg
Tablets containing 60 mg atogepant
Placebo Comparator: Placebo
Taken twice daily
 Drug: Placebo
30 mg/60 mg tablets containing atogepant-matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in mean monthly migraine days across the treatment period [ Time Frame: 12 Weeks ]
    Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.


Secondary Outcome Measures :
  1. Change from baseline in mean monthly headache days across the 12-week treatment period [ Time Frame: 12 Weeks ]
    Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.

  2. Change from baseline in mean monthly acute medication use days across the 12-week treatment period [ Time Frame: 12 Weeks ]
    Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date.

  3. At least a 50% reduction in 3-month average of monthly migraine days [ Time Frame: 12 Weeks ]
    Defined as participants with at least a 50% reduction from baseline in monthly migraine days

  4. Change from baseline in MSQ v2.1 Role Function-Restrictive domain score at Week 12 [ Time Frame: 12 Weeks ]
    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.

  5. 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) [ Time Frame: 12 Weeks ]
    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).

  6. 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) [ Time Frame: 12 Weeks ]
    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).

  7. Change from baseline in the Headache Impact Test (HIT-6) total score at Week 12 (Participants in Europe and Canada only) [ Time Frame: 12 Weeks ]
    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).


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855137


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: ALLERGAN INC. Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03855137    
Obsolete Identifiers: NCT04961671
Other Study ID Numbers: 3101-303-002
2018-004337-32 ( EudraCT Number )
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 and 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing, please refer to the link below
Access Criteria: 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.
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases