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

Study Identifier
191622-080
CT.gov Identifier
NCT00168428
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 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 phase.

    Study Locations

    Location
    Status
    Location
    Walnut Creek, California, United States
    Status
    Not applicable
    Location
    Calgary, Alberta, Canada
    Status
    Not applicable
    Location
    Zagreb, Croatia
    Status
    Not applicable
    Location
    Essen, Germany
    Status
    Not applicable
    Location
    Zurich, Switzerland
    Status
    Not applicable
    Location
    London, United Kingdom
    Status
    Not applicable