Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine (ATO-TOPIRAMATE)

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo for Atogepant; Drug: Topiramate; Drug: Atogepant; Drug: Placebo for Topiramate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05748483

2022-501172-25-00 (Other Identifier)

M22-061

Details and patient eligibility

About

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.

Enrollment: 545 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented history of migraine (with or without aura) for >= 12 months prior to screening (Visit 1).
• History of >= 4 migraine days per month who require preventive treatment of migraine and are eligible for conventional migraine prophylaxis.

Exclusion criteria

• Have used topiramate or atogepant in the past.
• Have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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545 participants in 2 patient groups

Atogepant

Experimental group

Description:

Participants will receive atogepant in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.

Treatment:

Drug: Placebo for Topiramate

Drug: Atogepant

Topiramate

Active Comparator group

Description:

Participants will receive topiramate in double-blind period. From Week 25, eligible participants will receive atogepant in open-label period.

Treatment:

Drug: Atogepant

Drug: Topiramate

Drug: Placebo for Atogepant