NCT00203190

A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache

A Single-Center, Randomized, Double-Blind, Placebo Controlled Trial Examining the Safety and Efficacy of Topiramate in the Treatment of Subjects With Episodic or Chronic Cluster Headache.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Topiramate is a medication that has been approved by the Food and Drug Administration (FDA) for the treatment of patients with seizures. The trade name for this drug is Topamax®. Topiramate has not been approved by the FDA for the treatment of cluster headache and is experimental for the purposes of this research study. If a subject participates in this study, he/she will increase his/her dose of topiramate rapidly in the first few weeks to try to stop the cluster attacks and then will continue on a maintenance dose of topiramate in order to determine if it can prevent attacks from occurring during that cluster period. We believe that this will lead not only to a faster but a more complete remission of the cluster period.

Conditions

• Cluster Headache

Interventions

Type	Name	Description
DRUG	Topiramate

Timeline

• Start date: 2004-09-01
• Completion: 2006-06-01
• First posted: 2005-09-20
• Last updated: 2009-01-23

Locations

1 site across 1 country: United States