Phase 4
Completed N=282
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
Migraine Disorders
Source: ClinicalTrials.gov NCT02191579 ↗
Enrolled (actual)
282
Serious AEs
2.8%
Results posted
Jun 2018
Primary outcomePrimary: 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
◆ Published Evidence
Highly cited
109citations · ~16 / year
FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine.
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.
Linked Publications (2)
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FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine.
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Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine.
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 |
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) and the linked publication. 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. Informational only — not medical advice.