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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
596
Tablets containing 60 mg of Atogepant
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Time frame: 156 weeks
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
Time frame: 156 weeks
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
Time frame: 156 weeks
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
Time frame: 156 weeks
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)
Time frame: 156 weeks
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Duplicate_Barrow Neurological Institute /ID# 228217
Phoenix, Arizona, United States
California Headache and Balance Center /ID# 226241
Fresno, California, United States
Duplicate_Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404
Los Alamitos, California, United States
Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389
Newport Beach, California, United States
Excell Research, Inc /ID# 228390
Oceanside, California, United States
Duplicate_Schuster Medical Research Institute /ID# 226246
Sherman Oaks, California, United States
Alpine Clinical Research Center /ID# 226203
Boulder, Colorado, United States
Sensible Healthcare /ID# 226426
Ocoee, Florida, United States
Accel Research Sites - Tampa Clinical Research Unit /ID# 226252
Tampa, Florida, United States
NeuroTrials Research Inc /ID# 226477
Atlanta, Georgia, United States
...and 106 more locations