Clinical Trial: Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

Brief Summary: The objective of this study is to assess the effectiveness and safety of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.

Detailed Summary: The objective of this study is to assess the efficacy and safety of topiramate in the prophylaxis of basilar migraine and hemiplegic migraine in children and adolescents, by comparing two doses, 25 and 100 mg/day.
Sponsor: Monarch Medical Research

Current Primary Outcome: The primary efficacy outcome will be the reduction in average monthly migraine-days over the entire double-blind phase relative to the prospective baseline period

Original Primary Outcome: The primary efficacy outcome will be the reduction in average monthly migraine-days over the entire double-blind phase relative to the prospective baseline period.

Current Secondary Outcome:

  • Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms
  • Reduction in migraine pain severity and duration
  • Reduction in migraine episode and headache episode frequency
  • Reduction in total headache days
  • Proportion of responders (i.e., the proportion of subjects who experience a ≥ 50% reduction in migraine-days and migraine episodes)
  • Cumulative reduction in frequency of migraine days and migraine episodes
  • Reduction in the use of acute/abortive medications
  • Reduction in migraine-associated symptoms


Original Secondary Outcome:

  • · Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms.
  • · Reduction in migraine pain severity and duration.
  • · Reduction in migraine episode and headache episode frequency.
  • · Reduction in total headache days.
  • · Proportion of responders (i.e., the proportion of subjects who experience a ³50% reduction in migraine-days and migraine episodes).
  • · Cumulative reduction in frequency of migraine days and migraine episodes.
  • · Reduction in the use of acute/abortive medications.
  • · Reduction in migraine-associated symptoms.


Information By: Monarch Medical Research

Dates:
Date Received: August 15, 2005
Date Started: February 2004
Date Completion: August 2006
Last Updated: November 9, 2012
Last Verified: November 2006