Overview

This trial is active, not recruiting.

Condition migraine disorders
Treatments onabotulinumtoxina, topiramate
Phase phase 4
Sponsor Allergan
Start date August 2014
End date September 2017
Trial size 280 participants
Trial identifier NCT02191579, FORWARD, GMA-US-NEU-0206

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
onabotulinumtoxina BOTOX®
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
(Active Comparator)
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®.
topiramate Topamax®
Topiramate up to a maximum oral dose of 100 mg/day.

Primary Outcomes

Measure
Percentage of Participants with a ≥ 50% Decrease from Baseline in the Frequency of Headache Days
time frame: Baseline, Week 32

Secondary Outcomes

Measure
Frequency of Headache Days
time frame: 32 Weeks
Headache Impact Test (HIT-6) Total Score
time frame: Week 32
Percentage of Participants with a ≥ 70% Decrease from Baseline in the Frequency of Headache Days
time frame: Baseline, Week 32

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title A Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of BOTOX® and Topiramate for Headache Prophylaxis in Adults With Chronic Migraine
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Allergan.