Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03939312|
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2019
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Episodic Migraine||Drug: Atogepant 60 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Multicenter, Open-Label 40-week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Participants With Episodic Migraine|
|Actual Study Start Date :||May 6, 2019|
|Estimated Primary Completion Date :||November 10, 2020|
|Estimated Study Completion Date :||November 10, 2020|
Taken orally once daily
Drug: Atogepant 60 mg
Tablet containing Atogepant 60 mg
- Percentage of Participants with at Least 1 Treatment Emergent Adverse Event [ Time Frame: 40 Weeks ]
- Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator [ Time Frame: 40 Weeks ]
- Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator [ Time Frame: 40 Weeks ]
- Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator [ Time Frame: 40 Weeks ]
- Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales [ Time Frame: 40 Weeks ]
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939312
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