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

Phase 1

Recruiting

• Conditions: Chronic and Episodic Migraine; MedDRA version: 21.1Level: LLTClassification code: 10066636Term: Chronic migraine Class: 10029205; MedDRA version: 22.0Level: LLTClassification code: 10082019Term: Episodic migraine Class: 10029205; MedDRA version: 20.0Level: PTClassification code: 10058734Term: Migraine prophylaxis Class: 100000004865; MedDRA version: 20.0Level: PTClassification code: 10027607Term: Migraine with aura Class: 100000004852; MedDRA version: 20.0Level: PTClassification code: 10052787Term: Migraine without aura Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2022-501172-25-00
• Lead Sponsor: Abbvie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-19
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the tolerability and safety of atogepant compared to the highest tolerated dose of topiramate in participants who require preventive treatment of migraine.;Secondary Objective: To demonstrate a higher rate of participants treated with atogepant versus topiramate achieving >= 50% improvement (reduction) in mean monthly migraine days (MMDs) during Months 4 to 6 of the Double Blind treatment period.;Primary end point(s): The primary endpoint is treatment discontinuation due to AEs during the 24-week DB treatment period

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Key Secondary Endpoint in Support of All Regions, including Germany HTA: Achievement of = 50% improvement (reduction) in mean MMD during Months 4 to 6 of the DB treatment period.;Secondary end point(s):Additional Key Secondary Endpoints in Support of France HTA Submission Only: Change from baseline in mean MMD during Months 4 to 6 of the DB treatment period;Secondary end point(s):Additional Key Secondary Endpoints in Support of France HTA Submission Only: Change from baseline in HIT-6 total score at Week 24;Secondary end point(s):Additional Key Secondary Endpoints in Support of France HTA Submission Only: Change from baseline in MSQ Version 2.1 RFR domain score at Week 24;Secondary end point(s):Additional Key Secondary Endpoints in Support of France HTA Submission Only: Achievement of a rating of much better or very much better at Week 24 assessed by the PGIC