Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
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|ClinicalTrials.gov Identifier: NCT03700320|
Recruitment Status : Completed
First Posted : October 9, 2018
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Episodic Migraine||Drug: Standard of Care (SOC) Migraine Preventive Medication Drug: Atogepant||Phase 3|
|Study Type :||Interventional|
|Actual Enrollment :||744 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Multicenter, Randomized, Open-label 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 :||October 8, 2018|
|Actual Primary Completion Date :||May 21, 2020|
|Actual Study Completion Date :||May 21, 2020|
Active Comparator: Oral SOC Migraine Preventive Medication
Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant.
Drug: Standard of Care (SOC) Migraine Preventive Medication
Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
Experimental: Atogepant 60 mg
Atogepant 60 mg tablet taken orally, once daily for 52 weeks.
Atogepant tablets taken orally, once daily for 52 weeks.
- Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE) [ Time Frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up ]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.
- Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator [ Time Frame: From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up ]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.
- Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator [ Time Frame: Up to Week 52 ]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.
- Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator [ Time Frame: From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up) ]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.
- Number of Participants With Most Severe Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation or Suicidal Behavior [ Time Frame: Up to Week 52 ]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.
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): NCT03700320
|Study Director:||Joel Trugman, MD||Allergan|