Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Topiramate

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.