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NCT04686136 Clinical Trial

A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

Chronic Migraine Clinical Trial

Official title:
A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04686136
Other study ID # 3101-312-002
Secondary ID 2020-002470-27
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 19, 2021
Est. completion date October 8, 2025

Study information
Verified date April 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atogepant 60 mg
Tablets containing 60 mg of Atogepant
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Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with at Least 1 Treatment Emergent Adverse Event 156 weeks
Secondary Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator 156 weeks
Secondary Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator 156 weeks
Secondary Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator 156 weeks
Secondary Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior) 156 weeks
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