HeadachePhase 2NCT00261469
An Open-label Study to Evaluate Topiramate Therapy in Migraine Patients, and Its Effects on Subject Responsiveness to Migraine Treatment With Triptans
A Phase 2 study testing topiramate in people with Headache, run by Janssen-Ortho Inc., Canada.
Trial summary
The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative use before a migraine attack) enhances the effectiveness of migraine treatment with triptans. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache
- What is being tested?
- topiramate
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Nov 2004
- Phase
- Phase 2
- 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 must have an established history consistent with migraine, with or without aura, confirming to International Headache Society (HIS) criteria for at least 6 months prior to study entry
- must be using a stable dose of triptan for migraine treatment for at least 3 migraine attacks per month
- must have failed <=2 previous prophylactic medications due to lack of effectiveness
- must have had between 3 and 12 migraine periods and no more than 18 headache days (migraine and non-migraine) during the 6-week Prospective Baseline Period. (A headache day is defined as a calendar day which the subject experienced headache pain for at least 4 hours untreated, or 30 minutes duration treated)
- female subjects who are postmenopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 1.
Who cannot join
- Subjects with headaches other than migraine with and/or without aura
- onset of migraine after age 50
- overuse analgesics or specific medications for treatment of migraine attacks
- currently on a prophylactic medication for migraine
- history of an unstable medical condition within the past 2 years, malignancy within the past 5 years, major psychiatric disorder within the past 6 months, suicidal ideations or suicide attempt within the past 2 years or history of alcohol or drug abuse within the past 6 months
About this study
Official title: Efficacy of Topiramate Prophylaxis as add-on to Triptan Therapy for Migraine
The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative use before a migraine attack) enhances the effectiveness of migraine treatment with triptans.
Read the detailed description
The objective of this pilot study is to determine if patients with migraine are more responsive to triptans taken for symptomatic headache treatment while on topiramate prophylactic therapy as compared to a baseline period without prophylaxis. The trial is an open-label design, with migraine patients receiving topiramate prophylactically twice a day (maximum of 200 mg/day) for 16 weeks, following a 6-week Prospective Baseline Period.
During the first week of the treatment phase, subjects will begin on a once-daily dose of 25 mg of topiramate at night, and remain on that dose for two weeks. Thereafter, the daily dose will be increased by 25 mg, with twice-daily dosing. If in the investigator's judgement further dosage increases beyond 100 mg/day are indicated, the daily dose will be increased weekly by 25 mg to a daily dose of 150 mg. The daily dose may be increased to a maximum daily dose of 200 mg, if the subject is tolerating the higher doses.
Subjects keep a headache diary in which the following information is recorded: time of onset of headache and indication of type of headache; time headache stops; any symptomatic treatment taken, time that tiptan medication is taken; headache intensity at the time the triptan is taken, 30 minutes, one hour, and two hours post dose; and the presence of nausea at the time the triptan is taken, 30 minutes, on hour, and 2 hours post dose. The primary measure of triptan responsiveness is the proportion of triptan treated migraine attacks that were pain-free at two hours after triptan treatment.
Safety evaluations during the study include the collection of adverse events, laboratory assessments including hematology, chemistry and urinalysis, and vital signs (blood pressure and pulse). The hypothesis is that topiramate prophylaxis will increase the responsiveness of migraine attacks to triptan therapy as measured by the proportion of attacks that are pain-free two hours after triptan therapy. Subjects will begin week 1 of the Topiramate Treatment phase with 25 mg topiramate at night. Thereafter, the dose of topiramate will be increased by 25 mg every second week i.e. week 3 = 50 mg, week 5 =75 mg, week 7 = 100 mg. If, in the investigator's judgment, further dosage increases are indicated, the dose can be increased as follows: week 9 = 125 mg, week 10 = 150 mg, week 11 = 175 mg, week 12 = 200 mgs.The dose may be increased weekly after week 10 if the patient is tolerating the higher.
- Conditions
- Headache
- Being tested
- topiramate
- Keywords
- Migraine, Headache
- Medical subject headings
- Headache, Migraine Disorders
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.
The proportion of migraine attacks that are pain-free two hours after triptan treatment, compared to baseline.
Secondary outcomes (1)
Pain relief at two hours after triptan treatment, compared to baseline; the proportion of migraine attacks that are pain-free 1 hour after triptan treatment, compared to baseline; adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study startApr 2003
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Ortho Inc., Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Ortho Inc. Clinical Trial, Study director, Janssen-Ortho Inc., Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261469
- Sponsor's protocol ID
- CR005686
- Status last verified
- Jan 2011
- First submitted
- 2 Dec 2005
- Last updated
- 17 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topiramate Prophylaxis as add-on to Triptan Therapy for Migraine
- ClinicalTrials.gov ID
- NCT00261469
- Acronym / sponsor ID
- CR005686
- Conditions
- Headache
- Keywords
- Migraine, Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Janssen-Ortho Inc., CanadaIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Nov 2004 (actual)
- First posted
- 5 Dec 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.
The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative use before a migraine attack) enhances the effectiveness of migraine treatment with triptans.
Detailed description
The objective of this pilot study is to determine if patients with migraine are more responsive to triptans taken for symptomatic headache treatment while on topiramate prophylactic therapy as compared to a baseline period without prophylaxis. The trial is an open-label design, with migraine patients receiving topiramate prophylactically twice a day (maximum of 200 mg/day) for 16 weeks, following a 6-week Prospective Baseline Period.
During the first week of the treatment phase, subjects will begin on a once-daily dose of 25 mg of topiramate at night, and remain on that dose for two weeks. Thereafter, the daily dose will be increased by 25 mg, with twice-daily dosing. If in the investigator's judgement further dosage increases beyond 100 mg/day are indicated, the daily dose will be increased weekly by 25 mg to a daily dose of 150 mg. The daily dose may be increased to a maximum daily dose of 200 mg, if the subject is tolerating the higher doses.
Subjects keep a headache diary in which the following information is recorded: time of onset of headache and indication of type of headache; time headache stops; any symptomatic treatment taken, time that tiptan medication is taken; headache intensity at the time the triptan is taken, 30 minutes, one hour, and two hours post dose; and the presence of nausea at the time the triptan is taken, 30 minutes, on hour, and 2 hours post dose. The primary measure of triptan responsiveness is the proportion of triptan treated migraine attacks that were pain-free at two hours after triptan treatment.
Safety evaluations during the study include the collection of adverse events, laboratory assessments including hematology, chemistry and urinalysis, and vital signs (blood pressure and pulse). The hypothesis is that topiramate prophylaxis will increase the responsiveness of migraine attacks to triptan therapy as measured by the proportion of attacks that are pain-free two hours after triptan therapy. Subjects will begin week 1 of the Topiramate Treatment phase with 25 mg topiramate at night. Thereafter, the dose of topiramate will be increased by 25 mg every second week i.e. week 3 = 50 mg, week 5 =75 mg, week 7 = 100 mg. If, in the investigator's judgment, further dosage increases are indicated, the dose can be increased as follows: week 9 = 125 mg, week 10 = 150 mg, week 11 = 175 mg, week 12 = 200 mgs.The dose may be increased weekly after week 10 if the patient is tolerating the higher.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have an established history consistent with migraine, with or without aura, confirming to International Headache Society (HIS) criteria for at least 6 months prior to study entry
- must be using a stable dose of triptan for migraine treatment for at least 3 migraine attacks per month
- must have failed <=2 previous prophylactic medications due to lack of effectiveness
- must have had between 3 and 12 migraine periods and no more than 18 headache days (migraine and non-migraine) during the 6-week Prospective Baseline Period. (A headache day is defined as a calendar day which the subject experienced headache pain for at least 4 hours untreated, or 30 minutes duration treated)
- female subjects who are postmenopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 1.
Key exclusion criteria (5 listed)
- Subjects with headaches other than migraine with and/or without aura
- onset of migraine after age 50
- overuse analgesics or specific medications for treatment of migraine attacks
- currently on a prophylactic medication for migraine
- history of an unstable medical condition within the past 2 years, malignancy within the past 5 years, major psychiatric disorder within the past 6 months, suicidal ideations or suicide attempt within the past 2 years or history of alcohol or drug abuse within the past 6 months
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
The proportion of migraine attacks that are pain-free two hours after triptan treatment, compared to baseline.
1 secondary outcome
Pain relief at two hours after triptan treatment, compared to baseline; the proportion of migraine attacks that are pain-free 1 hour after triptan treatment, compared to baseline; adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- Prophylactic Topiramate and Response to Triptan Treatment for Acute MigraineLink provided by the sponsor.
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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.
Janssen-Ortho Inc. Clinical Trial study director
Janssen-Ortho Inc., Canada
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing topiramate in people with Headache, run by Janssen-Ortho Inc., Canada.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of migraine attacks that are pain-free two hours after triptan treatment, compared to baseline.. 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 17 May 2011.