Vascular HeadachesPhase 3NCT00253175
A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine
A Phase 3 study testing topiramate in people with Vascular Headaches and Migraine, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate (an epilepsy medication) compared with placebo in the prevention of migraine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vascular Headaches, Migraine
- What is being tested?
- topiramate
- How many people
- 211 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Dec 2001
- Phase
- Phase 3
- 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
- Meet the criteria of the International Headache Society for the classification of migraine with or without aura (migraine symptoms)
- Diagnosis of migraine for at least 12 months prior to start of the study
- Have had an average of 3 to 8 migraine attacks per month for the 3 months prior to the start of the study
- Ability to recognize migraine headaches and to distinguish them from tension-type headaches or other types of head pain
- General good health
Who cannot join
- Patients who previously failed to respond to topiramate therapy for migraine prevention or who discontinued topiramate due to adverse events
- Patients who had onset of migraine after age 50
- Patients having more than 15 headache-days per month during the 3 months prior to start of the study, or during the baseline (pretreatment) period
- Patients who have cluster headaches or who have exclusively aura (migraine symptoms) without headache
- Female patients who are pregnant, nursing, or those not using adequate birth control, if capable of bearing children
About this study
Official title: A Comparison Of The Efficacy And Safety Of Topamax® (Topiramate) Tablets Versus Placebo For The Prophylaxis Of Migraine
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate (an epilepsy medication) compared with placebo in the prevention of migraine.
Read the detailed description
Topiramate is a medication that is widely used for the treatment of adult and pediatric patients with seizures and has been shown in preliminary studies to be effective for migraine prevention in adults. This is an outpatient, randomized, double-blind, placebo-controlled study to confirm preliminary studies of the effectiveness of topiramate in the prevention of migraine attacks. The study is composed of 4 phases: pretreatment, double-blind treatment for 20 weeks, a blinded transition, and an open-label extension. During the pretreatment phase patients discontinue all medication for migraine prevention and keep a daily record of headache information in a diary. Patients with 3 to 8 migraines, but not more than 15 headache days, during the pretreatment phase continue in the double-blind treatment phase. In the 20-week double-blind treatment phase, oral topiramate tablets (or placebo) are taken daily beginning at 25 mg once daily for 1 week, increasing to twice daily doses of up to a maximum of 8 tablets (200 mg) per day during the 8-week titration period, and maintained at that dose during the 12-week maintenance period. Patients who successfully complete the double-blind therapy phase may continue in an open-label extension (32 weeks), during which the study medication (topiramate or placebo) will be decreased and simultaneously topiramate (open-label) will be administered at increasing doses. During the study, patients will maintain headache and medication records to document the following: occurrence and duration of headaches; severity of headache pain; associated symptoms, such as nausea, vomiting, photophobia (avoidance and dread of light), phonophobia (fear of sound); and medication taken to relieve headache pain or symptoms. The primary measure of effectiveness is the percent reduction in the frequency of monthly migraine episodes during the entire double-blind treatment phase compared with the pretreatment phase. Other assessments of effectiveness include the percent of patients responding to treatment (>= 50% reduction in average monthly migraine attacks) during the double-blind treatment phase compared with the pretreatment phase, the reduction in number of migraine days/month during treatment, and the reduction in severity and duration of migraines during treatment. Safety assessments include the incidence of adverse events throughout the study, and measurement of vital signs (pulse, blood pressure, body weight), physical examinations, and clinical laboratory tests (hematology, biochemistry, and urinalysis) at specified intervals. The study hypothesis is that the decrease in the mean monthly migraine rate is greater in the topiramate group than in the placebo group.
Oral topiramate tablets 25 mg or placebo tablets, beginning at 25 mg once daily for 1 week, increasing to twice daily doses of up to a maximum of 8 tablets (200 mg) during the 8-week titration period, and maintained at that dose during the 12-week maintenance period (20 weeks total duration).
- Conditions
- Vascular Headaches, Migraine
- Being tested
- topiramate
- Keywords
- topiramate, migraine headache, migraine prevention, migraine
- Medical subject headings
- Vascular Headaches, 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.
Reduction in the frequency of monthly migraine episodes during the entire double-blind treatment phase compared with the pretreatment phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startOct 2000
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular HeadachesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253175
- Sponsor's protocol ID
- CR005572
- Status last verified
- Apr 2010
- First submitted
- 10 Nov 2005
- Last updated
- 28 Apr 2010
- Results posted
- No
Publications
Silberstein SD, Hulihan J, Karim MR, Wu SC, Jordan D, Karvois D, Kamin M. Efficacy and tolerability of topiramate 200 mg/d in the prevention of migraine with/without aura in adults: a randomized, placebo-controlled, double-blind, 12-week pilot study. Clin Ther. 2006 Jul;28(7):1002-11. doi: 10.1016/j.clinthera.2006.07.003.
PubMed 16990078
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of The Efficacy And Safety Of Topamax® (Topiramate) Tablets Versus Placebo For The Prophylaxis Of Migraine
- ClinicalTrials.gov ID
- NCT00253175
- Acronym / sponsor ID
- CR005572
- Conditions
- Vascular Headaches, Migraine
- Keywords
- topiramate, migraine headache, migraine prevention, migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Oct 2000
- Study completion
- Dec 2001 (actual)
- First posted
- 15 Nov 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 primary purpose of this study is to evaluate the effectiveness and safety of topiramate (an epilepsy medication) compared with placebo in the prevention of migraine.
Detailed description
Topiramate is a medication that is widely used for the treatment of adult and pediatric patients with seizures and has been shown in preliminary studies to be effective for migraine prevention in adults. This is an outpatient, randomized, double-blind, placebo-controlled study to confirm preliminary studies of the effectiveness of topiramate in the prevention of migraine attacks. The study is composed of 4 phases: pretreatment, double-blind treatment for 20 weeks, a blinded transition, and an open-label extension. During the pretreatment phase patients discontinue all medication for migraine prevention and keep a daily record of headache information in a diary. Patients with 3 to 8 migraines, but not more than 15 headache days, during the pretreatment phase continue in the double-blind treatment phase. In the 20-week double-blind treatment phase, oral topiramate tablets (or placebo) are taken daily beginning at 25 mg once daily for 1 week, increasing to twice daily doses of up to a maximum of 8 tablets (200 mg) per day during the 8-week titration period, and maintained at that dose during the 12-week maintenance period. Patients who successfully complete the double-blind therapy phase may continue in an open-label extension (32 weeks), during which the study medication (topiramate or placebo) will be decreased and simultaneously topiramate (open-label) will be administered at increasing doses. During the study, patients will maintain headache and medication records to document the following: occurrence and duration of headaches; severity of headache pain; associated symptoms, such as nausea, vomiting, photophobia (avoidance and dread of light), phonophobia (fear of sound); and medication taken to relieve headache pain or symptoms. The primary measure of effectiveness is the percent reduction in the frequency of monthly migraine episodes during the entire double-blind treatment phase compared with the pretreatment phase. Other assessments of effectiveness include the percent of patients responding to treatment (>= 50% reduction in average monthly migraine attacks) during the double-blind treatment phase compared with the pretreatment phase, the reduction in number of migraine days/month during treatment, and the reduction in severity and duration of migraines during treatment. Safety assessments include the incidence of adverse events throughout the study, and measurement of vital signs (pulse, blood pressure, body weight), physical examinations, and clinical laboratory tests (hematology, biochemistry, and urinalysis) at specified intervals. The study hypothesis is that the decrease in the mean monthly migraine rate is greater in the topiramate group than in the placebo group.
Oral topiramate tablets 25 mg or placebo tablets, beginning at 25 mg once daily for 1 week, increasing to twice daily doses of up to a maximum of 8 tablets (200 mg) during the 8-week titration period, and maintained at that dose during the 12-week maintenance period (20 weeks total duration).
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 (5 listed)
- Meet the criteria of the International Headache Society for the classification of migraine with or without aura (migraine symptoms)
- Diagnosis of migraine for at least 12 months prior to start of the study
- Have had an average of 3 to 8 migraine attacks per month for the 3 months prior to the start of the study
- Ability to recognize migraine headaches and to distinguish them from tension-type headaches or other types of head pain
- General good health
Key exclusion criteria (5 listed)
- Patients who previously failed to respond to topiramate therapy for migraine prevention or who discontinued topiramate due to adverse events
- Patients who had onset of migraine after age 50
- Patients having more than 15 headache-days per month during the 3 months prior to start of the study, or during the baseline (pretreatment) period
- Patients who have cluster headaches or who have exclusively aura (migraine symptoms) without headache
- Female patients who are pregnant, nursing, or those not using adequate birth control, if capable of bearing children
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
Reduction in the frequency of monthly migraine episodes during the entire double-blind treatment phase compared with the pretreatment phase.
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 28 Apr 2010.
- Results publication: PubMed 16990078Silberstein SD, Hulihan J, Karim MR, Wu SC, Jordan D, Karvois D, Kamin M. Efficacy and tolerability of topiramate 200 mg/d in the prevention of migraine with/without aura in adults: a randomized, placebo-controlled, double-blind, 12-week pilot study. Clin Ther. 2006 Jul;28(7):1002-11. doi: 10.1016/j.clinthera.2006.07.003.
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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topiramate in people with Vascular Headaches and Migraine, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 28 Apr 2010. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Reduction in the frequency of monthly migraine episodes during the entire double-blind treatment phase compared with the pretreatment phase.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00253175, which also lists 1 linked publication.
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 28 Apr 2010; AzTrials last refreshed its copy on 8 Nov 2026.