Open Label Study of BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Patients With Chronic Migraine

Study Identifier
1313-302-008
CT.gov Identifier
NCT03193359
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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:
    -Has successfully completed the double-blind study (1313-301-008).
    Exclusion Criteria:
    * Has met any of the withdrawal criteria in the double-blind study or has clinical significant abnormal laboratory or electrocardiogram (ECG) findings * Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma) * Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function.

    Protocol Summary

    This study is an open-label extension study to evaluate the safety, tolerability and efficacy of BOTOX® as headache prophylaxis in Chinese patients with chronic migraine who have successfully completed the double-blind study: 1313-301-008.

    Study Locations

    No locations found.