Status:
COMPLETED
Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.
Lead Sponsor:
Allergan
Conditions:
Episodic Migraine
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prop...
Eligibility Criteria
Inclusion
- At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
- Age of the participant at the time of migraine onset \< 50 years -History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment
- Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.
- 4 to 14 migraine days in the 28-day baseline period per eDiary
- Failed oral migraine prophylaxis medications from 2 to 4 medication classes
Exclusion
- Any clinically significant hematologic, endocrine, pulmonary, hepatic, gastrointestinal, or neurologic disease
- Participant has any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
- In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine
- Has ≥ 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment
- Has ≥ 15 headache days in the 28-day baseline period per eDiary
- Clinically significant cardiovascular or cerebrovascular disease
- Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018
- Has a current diagnosis of chronic migraine, new persistent daily headache, medication overuse headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2022
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT04740827
Start Date
March 5 2021
End Date
August 4 2022
Last Update
September 21 2023
Active Locations (114)
Enter a location and click search to find clinical trials sorted by distance.
1
Axiom Research /ID# 226379
Colton, California, United States, 92324
2
Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434
Encino, California, United States, 91316
3
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388
Los Alamitos, California, United States, 90720-3500
4
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405
Los Alamitos, California, United States, 90720-3500