Cluster HeadachePhase 4NCT00203190
A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache
A Phase 4 study testing Topiramate in people with Cluster Headache, run by Thomas Jefferson University at 1 site in United States.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Topiramate
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jun 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
About this study
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.
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
- Being tested
- Topiramate
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- William B Young, MD, Principal investigator, Thomas Jefferson University, Jefferson Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00203190
- Sponsor's protocol ID
- SDS/TOP-CL/01/CAPSS-322
- Other IDs
- 080-19000-H56501
- Status last verified
- Jan 2009
- First submitted
- 12 Sep 2005
- Last updated
- 23 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00203190
- Acronym / sponsor ID
- SDS/TOP-CL/01/CAPSS-322
- Conditions
- Cluster Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Sep 2004
- Study completion
- Jun 2006
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate | Drug | – |
Primary outcome
Change in the average daily frequency of moderate or severe attacks between baseline period to the period of day 14 to 56.
8 secondary outcomes
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William B Young, MD principal investigator
Thomas Jefferson University, Jefferson Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate in people with Cluster Headache, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the average daily frequency of moderate or severe attacks between baseline period to the period of day 14 to 56.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2009.