Clinical trial NCT00203190: A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cluster Headache
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Ortho-McNeil Neurologics, Inc.
First posted: 2005-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Change in the average daily frequency of moderate or severe attacks between baseline period to the period of day 14 to 56.
Secondary outcomes:
measure: Change in the average daily frequency of any attacks from the baseline period through the entire treatment period.
measure: Change in the average daily duration of any attacks from the baseline period through the entire treatment period.
measure: Change in the average daily attack severity from baseline period through the entire treatment period.
measure: Change in the average daily frequency of any attacks from the baseline period to each week during the treatment period.
measure: Change in the average daily duration of any attacks from the baseline period to each week during the treatment period.
measure: Change in the average daily attack severity from the baseline period to each week during the treatment period.
measure: Time to the first week from the baseline period with a 50% reduction in average daily frequency of moderate or severe attacks.
measure: Change in use of acute and rescue medications from the baseline period through the entire treatment period.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Jefferson Headache Center
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University, Jefferson Headache Center
name: William B Young, MD
role: PRINCIPAL_INVESTIGATOR
References: