Analgesic Rebound HeadachePhase 4NCT00432549
Detoxification and Treatment of Subjects With Medication Overuse Headache
A Phase 4 study testing Almotriptan and Topiramate in people with Analgesic Rebound Headache, run by The New England Center for Headache, P.C. at 1 site in United States.
Trial summary
The purpose of this study is to assess the benefits of almotriptan used as a transitional therapy and topiramate in subjects with medication overuse headaches (MOH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesic Rebound Headache
- What is being tested?
- Almotriptan and Topiramate
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Feb 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medication overuse headaches 18 years of age and older Must have a diagnosis of probable medication overuse headache Must have greater than fifteen headache days per month Must be in generally good health Female subjects must be postmenopausal or practicing an acceptable method of birth control
Who cannot join
- Not overusing six or more tablets per day of compounds containing barbituates opioids No overuse of triptans Previous failure or side effects with topiramate or almotriptan Cannot be pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The New England Center for Headache, P.C.
Stamford, Connecticut, 06902
Fred D Sheftell, M.D.
About this study
Official title: Evaluation of Almotriptan and Topiramate in the Detoxification and Treatment of Subjects With Medication Overuse Headache
The purpose of this study is to assess the benefits of almotriptan used as a transitional therapy and topiramate in subjects with medication overuse headaches (MOH.
- Conditions
- Analgesic Rebound Headache
- Being tested
- Almotriptan, Topiramate
- Keywords
- Medication overuse
- Medical subject headings
- Headache Disorders, Secondary, Prescription Drug Overuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmotriptanDrug
TopiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary measure for the detoxification period
Number of days with mild or no pain in the first two weeks of treatment
Primary for the prevention of relapse
Pain free days through day ninety
Secondary outcomes (4)
Primary measure for the detoxification period
Number of days without any headache in the first two weeks of treatment
Primary for the prevention of relapse
Headache frequency through day ninety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startJan 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic Rebound 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- The New England Center for Headache, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- Fred D Sheftell, M.D., Principal investigator, The New England Center for Headache, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432549
- Sponsor's protocol ID
- CAPSS-328
- Status last verified
- Feb 2007
- First submitted
- 6 Feb 2007
- Last updated
- 8 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Almotriptan and Topiramate in the Detoxification and Treatment of Subjects With Medication Overuse Headache
- ClinicalTrials.gov ID
- NCT00432549
- Acronym / sponsor ID
- CAPSS-328
- Conditions
- Analgesic Rebound Headache
- Keywords
- Medication overuse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- The New England Center for Headache, P.C.University, hospital or other
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Jan 2007
- Study completion
- Feb 2007
- First posted
- 8 Feb 2007 (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.
The purpose of this study is to assess the benefits of almotriptan used as a transitional therapy and topiramate in subjects with medication overuse headaches (MOH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Medication overuse headaches 18 years of age and older Must have a diagnosis of probable medication overuse headache Must have greater than fifteen headache days per month Must be in generally good health Female subjects must be postmenopausal or practicing an acceptable method of birth control
Key exclusion criteria (1 listed)
- Not overusing six or more tablets per day of compounds containing barbituates opioids No overuse of triptans Previous failure or side effects with topiramate or almotriptan Cannot be pregnant or lactating
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 |
|---|---|---|
| Almotriptan | Drug | – |
| Topiramate | Drug | – |
Primary outcome
Primary measure for the detoxification period
Number of days with mild or no pain in the first two weeks of treatment
Primary for the prevention of relapse
Pain free days through day ninety
4 secondary outcomes
Primary measure for the detoxification period
Number of days without any headache in the first two weeks of treatment
Primary for the prevention of relapse
Headache frequency through day ninety
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2007.
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.
Fred D Sheftell, M.D. principal investigator
The New England Center for Headache, P.C.
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 Almotriptan and Topiramate in people with Analgesic Rebound Headache, run by The New England Center for Headache, P.C. 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Feb 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alfredo DaSilva (203-322-2748, adasilva@nech.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary measure for the detoxification period. The study lists 4 primary outcomes in all. 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 8 Feb 2007.