Trial intelligence / Profile preview

Safety and Tolerability of Atogepant in Chinese Participants With Chronic Migraine

NCT04829747Phase 3

Key facts

Status: Completed
Start: Aug 2021
Primary completion: Jan 2022
Countries: 1
Sponsor: Allergan
Modality: Small Molecules

Drugs: atogepant
Conditions: chronic migraine

Overview

Phase 3, open-label, single-arm trial of atogepant in chronic migraine, sponsored by Allergan. Primary endpoints: Number of Participants With Adverse Events at 16 weeks, Number of Participants With Significant Change in Clinical Laboratory Determinations at 16 weeks and 3 more. Started Aug 2021; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Atogepant
Participants receive fixed dose of Atogepant once daily.

Who it enrols

Chinese adults with chronic migraine who completed the lead-in study 3101-303-002 without significant protocol deviations or unacceptable adverse events.

Endpoints

Primary

Number of Participants With Adverse Events16 weeks
Number of Participants With Significant Change in Clinical Laboratory Determinations16 weeks
Number of Participants With Significant Change in Vital Sign Measurements16 weeks
Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters12 weeks
Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS)16 weeks

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