Trials / Completed
CompletedNCT02191579
Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 282 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | onabotulinumtoxinA | 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks. |
| DRUG | Topiramate | Topiramate up to a maximum oral dose of 100 mg/day. |
Timeline
- Start date
- 2014-08-05
- Primary completion
- 2017-05-09
- Completion
- 2017-09-01
- First posted
- 2014-07-16
- Last updated
- 2018-06-07
- Results posted
- 2018-06-07
Locations
32 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02191579. Inclusion in this directory is not an endorsement.