| September 12, 2005 |
| January 22, 2009 |
| September 2004 |
| |
| Change in the average daily frequency of moderate or severe attacks between baseline period to the period of day 14 to 56. |
| •Change in the average daily frequency of moderate or severe attacks between baseline period to the period of day 14 to 56. |
| Complete list of historical versions of study NCT00203190 on ClinicalTrials.gov Archive Site |
- 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.
- Change in the average daily attack severity from the baseline period to each week during the treatment period.
- Time to the first week from the baseline period with a 50% reduction in average daily frequency of moderate or severe attacks.
- Change in use of acute and rescue medications from the baseline period through the entire treatment period.
|
- •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.
- •Change in the average daily attack severity from the baseline period to each week during the treatment period.
- •Time to the first week from the baseline period with a 50% reduction in average daily frequency of moderate or severe attacks.
- •Change in use of acute and rescue medications from the baseline period through the entire treatment period.
|
| |
| A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache |
| 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. |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Cluster Headache |
| Drug: Topiramate |
| |
| |
| |
| Terminated |
| 60 |
| June 2006 |
|
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
|
| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00203190 |
|
| SDS/TOP-CL/01/CAPSS-322, 080-19000-H56501 |
| Thomas Jefferson University |
| Ortho-McNeil Neurologics, Inc. |
| Principal Investigator: |
William B Young, MD |
Thomas Jefferson University, Jefferson Headache Center |
|
|
| Thomas Jefferson University |
| January 2009 |