Efficacy, Safety, and Tolerability of Multiple Dosing Regimens of Oral Atogepant (AGN-241689) in Episodic Migraine Prevention

• Status: Completed
• Trial end date: 2018-04-23
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and tolerability of the following doses of atogepant (AGN-241689): 10 mg once daily (QD), 30 mg QD, 30 mg twice daily (BID), 60 mg QD, and 60 mg BID for the prevention of episodic migraine and will characterize the dose/response relationship.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan

Criteria

Inclusion Criteria:

• Has at least a 1-year history of migraine with or without aura

• Age of the patient at the time of migraine onset < 50 years

• History of 4 to 14 migraine days (migraine/probable migraine headache days) per month on average in the 3 months prior to Visit 1 in the Investigator's judgment

• Demonstrated compliance with e-diary

Exclusion Criteria:

• Has a history of migraine accompanied by diplopia or decreased level of consciousness and retinal migraine

• Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy

• Difficulty distinguishing migraine headache from other headaches

• Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer

• Has a history of gastric or small intestinal surgery, or has a disease that causes malabsorption

• Has a history of hepatitis within previous 6 months

• Usage of opioids or barbiturates > 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1

• Pregnant or nursing females