Use of a Treatment Benefit Questionnaire in Patients With Chronic Migraine Treated With OnabotulinumtoxinA (BOTOX®)

Study Identifier
GMA-BTX-CM-12-545
CT.gov Identifier
NCT01833130
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 - Chronic
    • Study Drug
  • OnabotulinumtoxinA
  • Normal saline (placebo)
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * History of chronic migraine for at least 6 months prior to the screening visit * Fifteen or more headache days during the 4-week screening period (≥4 headache episodes lasting ≥4 hours and ≥50 % of headache days are migraine)
    Exclusion Criteria:
    * Conditions causing chronic facial pain such as Temporomandibular Disorder (TMD) and fibromyalgia * Use of headache prophylaxis medication within 4 weeks of the screening visit * Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis * Previous use of any botulinum toxin of any serotype for any reason * Skin infections or acne that would interfere with the injection sites * Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, nociceptive trigeminal inhibition, occipital nerve block treatments, or injection of anesthetics/steroids within 4 weeks of screening.

    Protocol Summary

    This study will evaluate the use of the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire in assessing the impact and benefit of treatment with onabotulinumtoxinA (BOTOX®) in adults with chronic migraine.

    Study Locations

    Location
    Status
    Location
    San Francisco, California, United States
    Status
    Not applicable