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

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ClinicalTrials.gov Identifier: NCT02191579
Recruitment Status : Completed
First Posted : July 16, 2014
Results First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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

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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

MedlinePlus Genetics related topics: Migraine

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 (First 28 days from Screening) to the last 28-day period ending with Week 32 ]
    Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.


Secondary Outcome Measures :
  1. Change From Baseline in the Frequency of Headache Days Per 28-day Period [ Time Frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32 ]
    Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. A negative change from Baseline (less headache days) indicates improvement.

  2. Change From Baseline in Headache Impact Test (HIT-6) Total Score [ Time Frame: Baseline (Day 1) to the last 28-day period ending with Week 30 ]

    The HIT-6 is a valid disease-targeted measure used to assess the impact of headaches, comprised of 6 items that assess pain, role functioning, social functioning, cognitive functioning, vitality, and psychological distress. A total score is created by summingacross all items, and ranges from 36 (no impact) to 78 (severe impact) reflecting a "best to worst" scoring.

    A negative change from Baseline (a lower score) indicates improvement.


  3. Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days [ Time Frame: Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32 ]
    Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 70% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.



Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT02191579


Locations
Show Show 32 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Esther Jo Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Statistical Analysis Plan  [PDF] July 17, 2017
Study Protocol  [PDF] May 27, 2014

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02191579    
Other Study ID Numbers: GMA-US-NEU-0206
FORWARD ( Other Identifier: Allergan )
First Posted: July 16, 2014    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: June 7, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
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
Anticonvulsants
Hypoglycemic Agents