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NCT02191579 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
A Phase 4 study of Migraine Disorders, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 282
- Enrollment target
- 20
- Study locations
NCT02191579: Completed Phase 4 study of Migraine Disorders, sponsored by Allergan.
NCT02191579 is a Phase 4 study of Migraine Disorders that has completed, run by Allergan. The registered enrollment target is 282 participants, roughly in line with the 302-participant average among 21 other Migraine Disorders trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02191579, a Phase 4 study of Migraine Disorders, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 282 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Topiramate
- BIOLOGICAL onabotulinumtoxinA
Study Locations (20)
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton Inc - Boca Raton
- Design Neuroscience Center - Doral
- NW FL Clinical Research Group, LLC - Gulf Breeze
- Negroski, Sutherland & Hanes Neurology - Sarasota
- Neurology Research Institute at Palm Beach Neurology - West Palm Beach
California
- North County Neurology Associates - Encinitas
- California Headache and Balance Center - Fresno
- Newport Beach Clinical Research Associates, Inc. - Newport Beach
Kansas
- International Clinical Research Institute Inc - Overland Park
- Kansas City Bone and Joint Clinic - Overland Park
Massachusetts
- MedVadis Research Corporation - Watertown
- New England Regional Headache Center Inc - Worcester
Missouri
- Clinvest - Springfield
- Mercy Health Research - St Louis
Arizona
- St Joseph's Hospital Barrow Neurology Clinics - Phoenix
Colorado
- Denver Neurological Clinic - Denver
Connecticut
- Ki Health Partners LLC DBA New England Institute for Neurology and Headache - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2014-08-05 |
| Est. Completion | 2017-09-01 |
| Phase | Phase 4 |
What the finished NCT02191579 record still lists
NCT02191579 is an interventional study that assigns participants to a tested intervention. The registered 282 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 302-participant average among 21 other Migraine Disorders trials with a reported enrollment target.
The record links to 1 condition, with Migraine Disorders appearing as the primary indexed condition, and to 2 interventions - of which Topiramate is the first listed.
NCT02191579 names 20 study sites across 11 states, led by Florida, California, Kansas.
Frequently Asked Questions
What is clinical trial NCT02191579 about?
NCT02191579 is a clinical study titled "Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults". This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.
What is the current status of trial NCT02191579?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 282 participants. The study started on 2014-08-05. Estimated completion is 2017-09-01.
What conditions does trial NCT02191579 study?
This clinical trial studies the following conditions: Migraine Disorders.
What interventions are being tested in trial NCT02191579?
The interventions under investigation include: Topiramate (DRUG), onabotulinumtoxinA (BIOLOGICAL).
Who is sponsoring clinical trial NCT02191579?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02191579 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02191579's enrollment target sits among peer trials
282 10th of 21 higher than 12 of 21 other Migraine Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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-
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