This study will evaluate safety and tolerability of treatment with atogepant for the prevention of episodic migraine over the course of one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
744
Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
Atogepant tablets taken orally, once daily for 52 weeks.
Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.
Time frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator
Laboratory tests included tests of hematology, chemistry, and urinalysis. The investigator determined if the results were potentially clinically significant (PCS). Only categories with at least one participant are reported.
Time frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator
A standard 12-lead ECG was performed. The investigator determined if the result was potentially clinically significant. Only categories with at least one participant are reported.
Time frame: Up to Week 52
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Vital sign measurements included sitting and standing blood pressure (BP), sitting and standing pulse rate, respiratory rate, temperature, and body weight. The investigator determined if the results were clinically significant. Only categories with at least one participant are reported.
Time frame: From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)
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Clinical Research Advantage, Inc./Simon Williamson Clinic, PC
Birmingham, Alabama, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Synexus Clinical Research US, Inc./East Valley Family Physicians PLC
Chandler, Arizona, United States
Synexus Clinical Research US, Inc./Desert Clinical Research, LLC
Mesa, Arizona, United States
Synexus Clinical Research US, Inc./Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Hope Clinical Research
Canoga Park, California, United States
Pharmacology Research Institute
Encino, California, United States
Sun Valley Research Center, Inc.
Imperial, California, United States
Irvine Center for Clinical Research
Irvine, California, United States
...and 102 more locations
Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was 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). Only the most severe suicidal ideation and the most severe suicidal behavior counted during the treatment period for at least 1 participant are reported.
Time frame: Up to Week 52