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To Evaluate the Safety and Tolerability of Atogepant 10mg, 30 mg and 60 mg Once a Day for the Prevention of Migraine in Participants With Episodic 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: NCT03777059
Recruitment Status : Completed
First Posted : December 17, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.

Condition or disease Intervention/treatment Phase
Episodic Migraine Drug: Atogepant 30 mg Drug: Atogepant 60 mg Drug: Placebo Drug: Atogepant 10 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 910 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine (Advance)
Actual Study Start Date : December 14, 2018
Actual Primary Completion Date : June 19, 2020
Actual Study Completion Date : June 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Atogepant 30 mg
Taken once daily
Drug: Atogepant 30 mg
Tablets containing atogepant 30 mg

Active Comparator: Atogepant 60 mg
Taken once daily
Drug: Atogepant 60 mg
Tablets containing atogepant 60 mg

Placebo Comparator: Placebo
Taken once daily
Drug: Placebo
10 mg, 30 mg and 60 mg tablets containing atogepant-matching placebo

Active Comparator: Atogepant 10 mg
Taken once daily
Drug: Atogepant 10 mg
Tablets containing atogepant 10 mg




Primary Outcome Measures :
  1. Change from baseline in mean monthly migraine 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 of the baseline phase, ie, Day -28 to -1.


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 of the baseline phase, ie, Day -28 to -1.

  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 acute medication use days during the last 28 days of the baseline phase, ie, Day-28 to -1.

  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 ]
    Migraine-Specific Quality of Life Questionnaire, version 2.1 (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 three 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. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life.

  5. Change from baseline in mean monthly performance of daily activities domain score of the AIM-D across the 12-week treatment period. [ Time Frame: 12 weeks ]

    Baseline is defined as the monthly performance of daily activities domain score during the last 28 days of the baseline phase, ie, Day -28 to -1.

    The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item Patient Reported Outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale ranging from "Not difficult at all," "A little difficult," "Somewhat difficult," "Very difficult," "Extremely difficult," and "I could not do it at all."


  6. Change from baseline in mean monthly physical impairment domain score of the AIM-D across the 12-week treatment period. [ Time Frame: 12 weeks ]

    Baseline is defined as the monthly physical impairment domain score during the last 28 days of the baseline phase, ie, Day -28 to -1.

    The Activity Impairment in Migraine - Diary (AIM-D) is a 9-item Patient Reported Outcome (PRO) measure that assesses the impact of migraine on the performance of daily activities and physical impairment using a 6-point rating scale ranging from "Not difficult at all," "A little difficult," "Somewhat difficult," "Very difficult," "Extremely difficult," and "I could not do it at all."




Information from the National Library of Medicine

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 migraine with or without aura consistent with a diagnosis.
  • Age of the participant at the time of migraine onset < 50 years.

Exclusion Criteria:

  • Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine
  • Has a current diagnosis of chronic migraine, 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
  • Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

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): NCT03777059


Locations
Show Show 138 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joel Trugman, MD Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03777059    
Other Study ID Numbers: 3101-301-002
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allergan:
Migraine
Aura
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases