Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine

Study Identifier
M21-307
CT.gov Identifier
NCT05028569
EudraCT Identifier
2021-001979-16
EUCTIS ID
Not available
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Protocol
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Statistical Analysis Plan
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Plain Language Summary
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Study Details

Medical Condition
  • Migraine - Episodic
    • Study Drug
  • BOTOX
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * History of migraine headache disorder meeting International Classification of Headache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migraine without aura for \>= 12 months. * Onset of migraine before 50 years of age. * History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1. * Six to 14 migraine/probable migraine days during the 4-week screening/baseline phase. * Less than 15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase.
    Exclusion Criteria:
    * Current diagnosis of chronic migraine according to ICHD-3. * History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, chronic tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache. * History of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma) with exception that medication overuse headache per ICHD-3 criteria is allowed. * History of inadequate response to \> 4 prophylactic treatment for migraine, 2 of which have different mechanisms of action. * Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or within 90 days after the last dose of study drug.

    Protocol Summary

    Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (International Classification of Headache Disorders, 2018). Migraine can be further categorized according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM.

    BOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world.

    Participants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Day 1 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Neurology and Neurodiagnostics of Alabama /ID# 231918
    Hoover, Alabama, United States, 35244-5700
    Status
    Not applicable
    Location
    Rehabilitation & Neurological Services /ID# 252441
    Huntsville, Alabama, United States, 35805-4046
    Status
    Not applicable
    Location
    Alea Research /ID# 233329
    Phoenix, Arizona, United States, 85012-2707
    Status
    Not applicable
    Location
    Duplicate_Barrow Neurological Institute /ID# 231799
    Phoenix, Arizona, United States, 85013-4407
    Status
    Not applicable
    Location
    Clinical Endpoints /ID# 232625
    Scottsdale, Arizona, United States, 85258-4595
    Status
    Not applicable
    Location
    Tucson Neuroscience Research /ID# 232288
    Tucson, Arizona, United States, 85710-6152
    Status
    Not applicable
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