Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

Sponsor
AbbVie
Study ID
NCT05748483
Phase
PHASE3
Status
Active Not Recruiting

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 that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. 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
Oct 7, 2023
Status verified
May 2025
Primary completion
Apr 28, 2025
Completion
May 31, 2026

Study Design

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

Arms

  • Experimental: Atogepant
    Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.
  • Active Comparator: Topiramate
    Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.

Primary Outcome Measure

Percentage of Participants Who Discontinued Treatment due to Adverse Events (AEs) [ Time Frame: Up to Week 24 (Double-blind treatment period) ]

Related Studies