Trials / Completed
CompletedNCT00158002
A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (planned)
- Sponsor
- Monarch Medical Research · Academic / Other
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the long-term safety and effectiveness of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.
Detailed description
This is a single-center, open-label study consisting of 3 phases: Blinded Transition Phase, Open-Label Maintenance Phase, and Taper/Exit Phase. Subjects who have either succesfully completed the CAPSS-271 protocol or who discontinued the CAPSS-271 study due to lack of effectiveness after completing at least 2 weeks of maintenance treatment will be eligible to enroll.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Topiramate |
Timeline
- Start date
- 2004-02-01
- Completion
- 2006-08-01
- First posted
- 2005-09-12
- Last updated
- 2007-04-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00158002. Inclusion in this directory is not an endorsement.