Clinical Trial: A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine
Brief 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 Summary: 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.
Sponsor: Monarch Medical Research
Current Primary Outcome:
- Reduction of average monthly migraine days
- Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms
- Reduction in migraine pain severity and duration
- Migraine episode and headache episode frequency
- Total headache days
- Proportion of responders (i.e., the proportion of subjects who experience a 50% reduction in migraine-days and migraine episodes)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Cumulative frequency of migraine days and migraine episodes
- Use of acute/abortive medications
- Migraine episode and headache episode frequency
- Total headache days
- Migraine-associated symptoms
Original Secondary Outcome: Same as current
Information By: Monarch Medical Research
Dates:
Date Received: September 7, 2005
Date Started: February 2004
Date Completion: August 2006
Last Updated: April 4, 2007
Last Verified: April 2007