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

Thomas Jefferson University

Status and phase

Terminated

Phase 4

Conditions

Cluster Headache

Treatments

Drug: Topiramate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00203190

SDS/TOP-CL/01/CAPSS-322

080-19000-H56501

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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