MigrainePhase 3NCT00210912
A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches
A Phase 3 study testing topiramate in people with Migraine, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo for the prevention of headaches in patients with chronic migraine. Topiramate has been approved to prevent migraine headaches as well as in the treatment of epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- topiramate
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Apr 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic migraine
- >=15 headache days per month in past 30 days
- >= 15 headache days, half of which need to be migraine headaches during the prospective baseline period
- MIDAS test score >= 11 at Visit 1
- In generally good health
- If female, using birth control
- No abnormalities on neurological examination
Who cannot join
- Failed > 2 adequate trials of migraine prevention medications
- Failed topiramate due to lack of effectiveness or adverse events
- Daily headaches of severe intensity during past 30 days
- Cluster, basilar, ophthalmoplegic, or hemiplegic migraines
- Migraines started after age 50
- Other pain greater than migraine pain
- Use of drugs to treat migraines for > 4 days per week during the past month
About this study
Official title: A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Chronic Migraine
The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo for the prevention of headaches in patients with chronic migraine. Topiramate has been approved to prevent migraine headaches as well as in the treatment of epilepsy.
Read the detailed description
Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication, has been shown to help prevent migraine headaches from occurring. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study of patients with chronic migraine. The Pretreatment Phase for the study will last up to 56 days and will consist of 2 study periods: a Screening/Washout Period (Day -56 to Day -29) and a Prospective Baseline Period (28 days). Medications being used to prevent migraines will be stopped for 14 to 28 days prior to the Prospective Baseline Period and for the rest of the study. The Prospective Baseline Period will begin on study Day -28 (Visit 2), and patients will maintain a daily headache record during this period. Those who move forward in the study must have had at least 15 headache days during this period, half of which need to be migraine headache days. Patients who finish the Prospective Baseline Period, who have the required rates of headache, and who continue to meet the remainder of the entry criteria will be randomized (like with the toss of a coin) to 1 of 2 treatment groups: topiramate 100 milligrams per day or placebo. The Double-Blind Phase will last 16 weeks. During the first 4 weeks, patients will titrate up to the topiramate dose of 100 milligrams per day or to the maximum tolerated dose, whichever is less. The next 12 weeks is the maintenance phase where you will continue to take the dose that you were taking at the end of the 4-week titration period. The primary hypothesis of this study is that the mean decrease in the number of migraine/migrainous headache days per month is greater in the topiramate group than in the placebo group and topiramate is generally well-tolerated.
Topiramate 25 milligram tablets, 2 tablets by mouth twice daily, or maximum tolerated dose, whichever is less, for 12 weeks, or 2 placebo tablets twice daily for 12 weeks
- Conditions
- Migraine
- Being tested
- topiramate
- Keywords
- prevention, Migraine, chronic, headache
- Medical subject headings
- Migraine Disorders, Bronchiolitis Obliterans Syndrome, 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 number of days per month with migraine or migrainous headache by daily headache record.
Secondary outcomes (1)
Absolute change and % change from baseline in the headache index; change in the average daily and worst daily headache severity; quality of life assessments (MIDAS, MSQ, Physician's/Subject's global assessments of change.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2003
- Study completionApr 2005
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 MigraineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 328 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
- NCT00210912
- Sponsor's protocol ID
- CR004684
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
Publications
Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N, Brandes JL, Bigal M, Saper J, Ascher S, Jordan DM, Greenberg SJ, Hulihan J; Topiramate Chronic Migraine Study Group. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007 Feb;47(2):170-80. doi: 10.1111/j.1526-4610.2006.00684.x.
PubMed 17300356
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy and Safety of Topiramate Versus Placebo for the Prophylaxis of Chronic Migraine
- ClinicalTrials.gov ID
- NCT00210912
- Acronym / sponsor ID
- CR004684
- Conditions
- Migraine
- Keywords
- prevention, Migraine, chronic, headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho-McNeil Neurologics, Inc.
- Study start
- Sep 2003
- Study completion
- Apr 2005 (actual)
- First posted
- 21 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.
The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo for the prevention of headaches in patients with chronic migraine. Topiramate has been approved to prevent migraine headaches as well as in the treatment of epilepsy.
Detailed description
Migraine headaches can be disabling and can interfere with work and a person's quality of life. Preventing these headaches before they start is the best option. Topiramate, an anti-seizure medication, has been shown to help prevent migraine headaches from occurring. This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study of patients with chronic migraine. The Pretreatment Phase for the study will last up to 56 days and will consist of 2 study periods: a Screening/Washout Period (Day -56 to Day -29) and a Prospective Baseline Period (28 days). Medications being used to prevent migraines will be stopped for 14 to 28 days prior to the Prospective Baseline Period and for the rest of the study. The Prospective Baseline Period will begin on study Day -28 (Visit 2), and patients will maintain a daily headache record during this period. Those who move forward in the study must have had at least 15 headache days during this period, half of which need to be migraine headache days. Patients who finish the Prospective Baseline Period, who have the required rates of headache, and who continue to meet the remainder of the entry criteria will be randomized (like with the toss of a coin) to 1 of 2 treatment groups: topiramate 100 milligrams per day or placebo. The Double-Blind Phase will last 16 weeks. During the first 4 weeks, patients will titrate up to the topiramate dose of 100 milligrams per day or to the maximum tolerated dose, whichever is less. The next 12 weeks is the maintenance phase where you will continue to take the dose that you were taking at the end of the 4-week titration period. The primary hypothesis of this study is that the mean decrease in the number of migraine/migrainous headache days per month is greater in the topiramate group than in the placebo group and topiramate is generally well-tolerated.
Topiramate 25 milligram tablets, 2 tablets by mouth twice daily, or maximum tolerated dose, whichever is less, for 12 weeks, or 2 placebo tablets twice daily for 12 weeks
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 (7 listed)
- Diagnosis of chronic migraine
- >=15 headache days per month in past 30 days
- >= 15 headache days, half of which need to be migraine headaches during the prospective baseline period
- MIDAS test score >= 11 at Visit 1
- In generally good health
Key exclusion criteria (7 listed)
- Failed > 2 adequate trials of migraine prevention medications
- Failed topiramate due to lack of effectiveness or adverse events
- Daily headaches of severe intensity during past 30 days
- Cluster, basilar, ophthalmoplegic, or hemiplegic migraines
- Migraines started after age 50
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 number of days per month with migraine or migrainous headache by daily headache record.
1 secondary outcome
Absolute change and % change from baseline in the headache index; change in the average daily and worst daily headache severity; quality of life assessments (MIDAS, MSQ, Physician's/Subject's global assessments of change.
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 10 Jun 2011.
- Results publication: PubMed 17300356Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N, Brandes JL, Bigal M, Saper J, Ascher S, Jordan DM, Greenberg SJ, Hulihan J; Topiramate Chronic Migraine Study Group. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007 Feb;47(2):170-80. doi: 10.1111/j.1526-4610.2006.00684.x.
- Prophylaxis Chronic 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.
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 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 7 inclusion and 7 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 10 Jun 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 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?
Change in the average number of days per month with migraine or migrainous headache by daily headache record.. 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 NCT00210912, 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 10 Jun 2011.