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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02191579
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : October 13, 2017
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Biological: onabotulinumtoxinA Drug: Topiramate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : August 5, 2014
Actual Primary Completion Date : May 9, 2017
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: BOTOX®
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments.
Biological: onabotulinumtoxinA
155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Active Comparator: Topiramate
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®.
Drug: Topiramate
Topiramate up to a maximum oral dose of 100 mg/day.
Other Name: Topamax®

Primary Outcome Measures :
  1. Percentage of Participants with a ≥ 50% Decrease from Baseline in the Frequency of Headache Days [ Time Frame: Baseline, Week 32 ]

Secondary Outcome Measures :
  1. Frequency of Headache Days [ Time Frame: 32 Weeks ]
  2. Headache Impact Test (HIT-6) Total Score [ Time Frame: Week 32 ]
  3. Percentage of Participants with a ≥ 70% Decrease from Baseline in the Frequency of Headache Days [ Time Frame: Baseline, Week 32 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02191579

  Show 35 Study Locations
Sponsors and Collaborators
Study Director: Esther Jo Allergan

Responsible Party: Allergan Identifier: NCT02191579     History of Changes
Other Study ID Numbers: GMA-US-NEU-0206
FORWARD ( Other Identifier: Allergan )
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents