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

Study Identifier
CGP-MD-01
CT.gov Identifier
NCT02848326
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Migraine - General
    • Study Drug
  • Atogepant
  • Placebo-matching Atogepant
    • Phase
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion 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

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Achieve Clinical Research
    Birmingham, Alabama, United States, 35216
    Status
    Not applicable
    Location
    Radiant Research, Inc.
    Chandler, Arizona, United States, 85224
    Status
    Not applicable
    Location
    The Research Center of Southern California, LLC
    Carlsbad, California, United States, 92011
    Status
    Not applicable
    Location
    Neuro-Pain Medical Center, Inc
    Fresno, California, United States, 93710
    Status
    Not applicable
    Location
    Irvine Center for Clinical Research
    Irvine, California, United States, 92618
    Status
    Not applicable
    Location
    Downtown LA Research Center, Inc.
    Los Angeles, California, United States, 90017
    Status
    Not applicable
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