Status:
TERMINATED
A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Ortho-McNeil Neurologics, Inc.
Conditions:
Cluster Headache
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 be...
Eligibility Criteria
Inclusion
- Subjects between the ages of 18 and 65 with a diagnosis of cluster headache (episodic or chronic) as defined by the International Classification of Headache Disorders (2nd edition)
- Subjects must have a lifetime prevalence of at least 2 prior cluster cycles.
- Subjects must experience one or more attacks/ day during baseline period
- Subjects must have a typical cluster period lasting at least 8 weeks. Subjects must present in active cluster period and the expected remaining duration of the cluster cycle must be at least 8 weeks from Baseline visit.
- Subjects with other headache types are eligible provided the subject is able to differentiate these headaches from cluster headaches.
- Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
- Subject has negative urine pregnancy test prior to study entry, if female of child-bearing potential
- Subject is able to understand and comply with all study requirements
- Subject provides written informed consent prior to any screening procedures being conducted
Exclusion
- Women who are pregnant or lactating
- Subjects who, in the investigators opinion, have a history or have evidence of a medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
- Subjects who require a change in medication or existing regimen of medication for the prophylaxis of cluster in the 4 weeks prior to Baseline visit and for the duration of the trial
- Subjects who have cluster headaches that typically exceed 4 hours
- Subjects who have used the following medications/ treatments from four weeks prior to Baseline visit: corticosteroids and nerve blocks.
- Subjects using any drug which might interact adversely with, or interfere with the action of, the study medication (e.g., carbonic anhydrase inhibitors)
- Subjects who have failed an adequate trial of topiramate for cluster headaches due to lack of efficacy or adverse events, as determined by the investigator
- Subjects with a history of nephrolithiasis.
- Subjects who are allergic to or have shown hypersensitivity topiramate or agents similar to topiramate
- Subjects who abuse opioids as determined by investigator
- Subjects with a history of significant drug or alcohol abuse within the past year
- Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00203190
Start Date
September 1 2004
End Date
June 1 2006
Last Update
January 23 2009
Active Locations (1)
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1
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107