A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches

Study Identifier
191622-079
CT.gov Identifier
NCT00156910
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Migraine - General
    • Study Drug
  • Botulinum Toxin Type A
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Frequent migraine (\>=15 headache days per month) * \>=4 distinct headache episodes lasting \>=4 hours * \>=50% of baseline headache days migraine/probable migraine days
    Exclusion Criteria:
    * Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype * Any medical condition that puts the patient at increased risk with exposure to BOTOX * Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache * Use of prophylactic headache medication within 28 days prior to week -4 * Unremitting headache lasting continuously throughout the 4-week baseline period * Known or suspected Temporomandibular Disorders (TMD) * Diagnosis of fibromyalgia * Beck depression inventory score \>24 at week-4 * Psychiatric problems that may have interfered with study participation

    Protocol Summary

    This is a 60 week study including a double-blind phase followed by an open-label extension phase.

    Study Locations

    Location
    Status
    Location
    Seattle, Washington, United States
    Status
    Not applicable
    Location
    Markham, Ontario, Canada
    Status
    Not applicable