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Clinical trial

Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events and Disease Activity in Adult Participants With Migraine (TEMPLE)

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Last updated:27th Feb 2023
Status: Not yet recruiting
Identifier: NCT05748483
Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events and Disease Activity in Adult Participants With Migraine (TEMPLE)

Brief Summary:

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), safety, and efficacy (whether treatment works to prevent migraine symptoms) of atogepant compared to topiramate in patients with migraine.

Atogepant is a medicine currently approved in the United States, Canada and Israel 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.

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)
Estimated Study Start Date: June 30, 2023
Estimated Primary Completion Date: February 16, 2024
Estimated Study Completion Date: December 27, 2025

- Experimental: Atogepant
- Active Comparator: Topiramate

Category Value
Study type(s) Interventional
Estimated enrolment 520
Estimated Study start date 30 June 2023
Estimated study completion date 27 December 2025

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