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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855137
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : December 16, 2020
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)
Estimated 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
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

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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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


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@allergan.com

Locations
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Sponsors and Collaborators
Allergan
More Information
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Additional Information:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03855137    
Other Study ID Numbers: 3101-303-002
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: 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