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Philadelphia, Pennsylvania 19107


Purpose:

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.


Criteria:

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


NCT ID:

NCT00203190


Primary Contact:

Principal Investigator
William B Young, MD
Thomas Jefferson University, Jefferson Headache Center


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19107
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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