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 |
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.
(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
We found this trial at
75
sites
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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9 Medical Parkway
Dallas, Texas 75234
Dallas, Texas 75234
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75 Kings Highway Cutoff
Fairfield, Connecticut 06824
Fairfield, Connecticut 06824
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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8122 Datapoint Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
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5887 Glenridge Drive
Sandy Springs, Georgia 30328
Sandy Springs, Georgia 30328
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