A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
- Registration Number
- NCT04686136
- Lead Sponsor
- AbbVie
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 596
- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.
- Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
- Participants with an ECG indicating clinically significant abnormalities at Visit 1.
- Participants with hypertension at Visit 1.
- Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
- Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atogepant 60 mg Atogepant 60 mg Taken once daily
- Primary Outcome Measures
Name Time Method Percentage of Participants with at Least 1 Treatment Emergent Adverse Event 156 weeks
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator 156 weeks Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator 156 weeks Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales 156 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)
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator 156 weeks
Trial Locations
- Locations (116)
Duplicate_Barrow Neurological Institute /ID# 228217
🇺🇸Phoenix, Arizona, United States
Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
🇺🇸Los Alamitos, California, United States
Duplicate_Schuster Medical Research Institute /ID# 226246
🇺🇸Sherman Oaks, California, United States
Albuquerque Clinical Trials, Inc. /ID# 226523
🇺🇸Albuquerque, New Mexico, United States
Duplicate_Hôpital Pierre Wertheimer /ID# 226430
🇫🇷Bron, Rhone, France
AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 226220
🇫🇷Paris, France
Velocity Clinical Research /ID# 226307
🇩🇪Wiesbaden, Germany
IRCCS San Raffaele /ID# 228436
🇮🇹Rome, Roma, Italy
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 228630
🇮🇹Roma, Italy
Duplicate_Pusan National University Hospital /ID# 231416
🇰🇷Busan, Busan Gwang Yeogsi, South Korea
Scroll for more (106 remaining)Duplicate_Barrow Neurological Institute /ID# 228217🇺🇸Phoenix, Arizona, United States