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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training


Related Conditions & MeSH terms


NCT number NCT00158002
Study type Interventional
Source Monarch Medical Research
Contact
Status Completed
Phase Phase 2
Start date February 2004
Completion date August 2006

See also
  Status Clinical Trial Phase
Completed NCT00131443 - Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine Phase 2/Phase 3