Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 400
Inclusion Criteria
- More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
- History of chronic migraine
- More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
- History of chronic migraine
Exclusion Criteria
- Previous treatment with botulinum toxin of any serotype for any reason
- On a ketogenic diet (high in fat, low in carbohydrates)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
- ...
- Previous treatment with botulinum toxin of any serotype for any reason
- On a ketogenic diet (high in fat, low in carbohydrates)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
- Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
- Previous treatment with topiramate
- Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
- History of acute myopia or increased intraocular pressure
Summary
- Conditions
- Migraine Disorders
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Inclusion Criteria
- More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
- History of chronic migraine
- More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).
- History of chronic migraine
Exclusion Criteria
- Previous treatment with botulinum toxin of any serotype for any reason
- On a ketogenic diet (high in fat, low in carbohydrates)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
- ...
- Previous treatment with botulinum toxin of any serotype for any reason
- On a ketogenic diet (high in fat, low in carbohydrates)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
- Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.
- Previous treatment with topiramate
- Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
- History of acute myopia or increased intraocular pressure
Tracking Information
- NCT #
- NCT02191579
- Collaborators
- Not Provided
- Investigators
- Study Director: Esther Jo Allergan
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