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

NCT00203190 | Terminated Phase 4

• 2 other identifiers: SDS/TOP-CL/01/CAPSS-322080-19000-H56501
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cluster Headache

Outcome Measures

Primary Outcomes (1)

• Change in the average daily frequency of moderate or severe attacks between baseline period to the period of day 14 to 56.

Secondary Outcomes (8)

• Change in the average daily frequency of any attacks from the baseline period through the entire treatment period.

• Change in the average daily duration of any attacks from the baseline period through the entire treatment period.

• Change in the average daily attack severity from baseline period through the entire treatment period.

• Change in the average daily frequency of any attacks from the baseline period to each week during the treatment period.

• Change in the average daily duration of any attacks from the baseline period to each week during the treatment period.

Interventions

Topiramate DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Ortho-McNeil Neurologics, Inc.: collaborator

Study Sites (1)

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Cluster Headache

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• William B Young, MD

  Thomas Jefferson University, Jefferson Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2004
• Study Completion: June 1, 2006
• Last Updated: January 23, 2009

Record last verified: 2009-01

Locations

US (1)