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

Allergan

Status and phase: Completed; Phase 4

Conditions: Migraine Disorders

Treatments: Biological: onabotulinumtoxinA; Drug: Topiramate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02191579

FORWARD

GMA-US-NEU-0206

Details and patient eligibility

About

This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.

Enrollment: 282 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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282 participants in 2 patient groups

BOTOX®

Active Comparator group

Description:

155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.

Treatment:

Biological: onabotulinumtoxinA

Topiramate

Active Comparator group

Description:

Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®.

Treatment:

Drug: Topiramate