Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

Sponsor
AbbVie
Study ID
NCT05861427
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Key Dates

Start date
Jul 12, 2023
Status verified
May 2026
Primary completion
Mar 1, 2025
Completion
Mar 1, 2025

Study Design

Enrollment
524 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atogepant Dose A
    Participants will receive atogepant dose A once daily (QD) for 24 weeks.
  • Experimental: Atogepant Dose B
    Participants will receive atogepant dose B QD for 24 weeks.
  • Experimental: Atogepant Dose C
    Participants will receive atogepant dose C QD for 24 weeks.
  • Experimental: Placebo
    Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD for 12 weeks.

Primary Outcome Measure

Change From Baseline in Mean Monthly Migraine Days [ Time Frame: Up to Week 12 ]

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