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



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:12/8/2018
Start Date:September 6, 2016
End Date:April 23, 2018

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A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Dosing Regimens Of Oral AGN-241689 In Episodic Migraine Prevention

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.


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
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