Phase 4
N=282
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
Migraine Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02191579 ↗Enrolled (actual)
282
Serious AEs
2.8%
Results posted
Jun 2018
Primary outcome: Primary: Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days — 40.0; 12.0 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- onabotulinumtoxinA (Biological); Topiramate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days |
40.0; 12.0 | <0.001 sig |
| SECONDARY Change From Baseline in the Frequency of Headache Days Per 28-day Period |
-8.3; -2.1 | <0.001 sig |
| SECONDARY Change From Baseline in Headache Impact Test (HIT-6) Total Score |
-5.6; -1.3 | <0.001 sig |
| SECONDARY Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days |
27.1; 8.5 | <0.001 sig |
Summary
This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
- Previous treatment with botulinum toxin of any serotype for any reason
- Previous treatment with topiramate
- On a ketogenic diet (high in fat, low in carbohydrates)
- History of acute myopia or increased intraocular pressure
- 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.
Data sourced from ClinicalTrials.gov (NCT02191579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.