A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

Sponsor
AbbVie
Study ID
NCT04437433
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in Japanese participants with chronic (CM) or episodic migraine (EM).

Key Dates

Start date
Jun 18, 2020
Status verified
Jul 2025
Primary completion
Jun 11, 2024
Completion
Jun 11, 2024

Study Design

Enrollment
186 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atogepant 60 mg Chronic Migraine
    Participants with chronic migraine (CM) who completed lead-in Study 3101-303-002 (NCT03855137) received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks.
  • Experimental: Atogepant 60 mg Episodic Migraine
    Participants with episodic migraine (EM) who were newly recruited and met all study entry criteria received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks.

Primary Outcome Measure

Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) [ Time Frame: From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks) ]

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