MigrainePhase 3NCT00216606
The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine
A Phase 3 study testing topiramate in people with Migraine, run by Janssen Pharmaceutica N.V., Belgium.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of individualized doses (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of chronic migraine headaches over a period of 16 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- topiramate
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Jul 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of migraine for >= 1 year
- Headache type meets HIS (International Headache Society) criteria for migraine
- History reflects "chronic" headache--an average of >= 15 migraine days per month in the 3 months preceding trial entry
- History of chronic migraine for >=1 year>=15 headaches per month with an average duration of 4 hours if not treated
- Patient is otherwise neurologically and physically healthy on a pre-trial exam.
Who cannot join
- Any other type of chronic headache (besides migraine) from section 2 to 13 of the International Headache Society classification or headache resulting directly resulting some other factor (except for medication overuse)
- Onset of migraine after age 50
- Use of an anticonvulsant drug in the month prior to trial entry
- Use of an antidepressant unless dose has been used at a stable dose for >=3 months
- Use of migraine prevention medicine in the 3 months prior to trial entry unless the drug has been used for at least 3 months and used at a stable dose for at least a month
- Use of a carbonic anhydrase inhibitor such as acetazolamide (used to treat high blood pressure, glaucoma and seizures) or triamterene (a "water pill" for swelling and high blood pressure).
About this study
Official title: A Randomized Double-Blind Placebo Controlled Trial to Investigate the Efficacy and Tolerability of Topiramate in the Prophylaxis of Chronic Migraine
The purpose of this study is to evaluate the safety and effectiveness of individualized doses (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of chronic migraine headaches over a period of 16 weeks.
Read the detailed description
Previous studies have shown that topiramate is effective in preventing chronic migraine headaches. This study will start with a 4-week baseline period in which no treatment is given, followed by a 12-week period in which each patient's dose is adjusted and then kept stable for the last 4 weeks of the 16-week double-blind phase. The individualized dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day. Patients who are randomized to receive topiramate will remain on the optimized dose. The comparison phase of the study is a 16-week period in which the change in migraine days of patients on topiramate (taking at least 50 milligrams per day) is compared with the change in migraine days for patients on the placebo. Also studied will be the patients' health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients' views of the safety and tolerability of topiramate. The study hypothesis is that the number of migraine days, periods, and attacks from the baseline period to the last 4 weeks in the double-blind period is reduced more in the topiramate group than the placebo group. During the 16-week comparison period, patients will take by mouth a dose of 50 milligrams to 200 milligrams of topiramate daily.
- Conditions
- Migraine
- Being tested
- topiramate
- Keywords
- Chronic migraine, Migraine, Headache, Migraine headache, Topiramate
- Medical subject headings
- Migraine Disorders, 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 migraine days, migraine periods, and migraine attacks compared between the topiramate group and placebo group at the last month of the baseline phase and the last month of the placebo-controlled phase
Secondary outcomes (1)
Health-related quality of life as recorded in patient questionnaires (MIDAS, HIT-6, MSQ) over 16 double-blind weeks; Patient's satisfaction with the effectiveness and safety of topiramate; Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutica N.V. Clinical Trial, Study director, Janssen Pharmaceutica N.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216606
- Sponsor's protocol ID
- CR003928
- Status last verified
- Jan 2011
- First submitted
- 13 Sep 2005
- Last updated
- 1 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo Controlled Trial to Investigate the Efficacy and Tolerability of Topiramate in the Prophylaxis of Chronic Migraine
- ClinicalTrials.gov ID
- NCT00216606
- Acronym / sponsor ID
- CR003928
- Conditions
- Migraine
- Keywords
- Chronic migraine, Migraine, Headache, Migraine headache, Topiramate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Study completion
- Jul 2005 (actual)
- First posted
- 22 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 evaluate the safety and effectiveness of individualized doses (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of chronic migraine headaches over a period of 16 weeks.
Detailed description
Previous studies have shown that topiramate is effective in preventing chronic migraine headaches. This study will start with a 4-week baseline period in which no treatment is given, followed by a 12-week period in which each patient's dose is adjusted and then kept stable for the last 4 weeks of the 16-week double-blind phase. The individualized dose will start at 25 milligrams of topiramate per day and will be increased 25 milligrams per day once weekly and then raised to either the target--100 milligrams per day--or the maximum dose that is well tolerated up to 200 milligrams per day. Patients who are randomized to receive topiramate will remain on the optimized dose. The comparison phase of the study is a 16-week period in which the change in migraine days of patients on topiramate (taking at least 50 milligrams per day) is compared with the change in migraine days for patients on the placebo. Also studied will be the patients' health-related quality of life as assessed by questionnaires filled out at specific visits as well as the patients' views of the safety and tolerability of topiramate. The study hypothesis is that the number of migraine days, periods, and attacks from the baseline period to the last 4 weeks in the double-blind period is reduced more in the topiramate group than the placebo group. During the 16-week comparison period, patients will take by mouth a dose of 50 milligrams to 200 milligrams of topiramate daily.
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)
- History of migraine for >= 1 year
- Headache type meets HIS (International Headache Society) criteria for migraine
- History reflects "chronic" headache--an average of >= 15 migraine days per month in the 3 months preceding trial entry
- History of chronic migraine for >=1 year>=15 headaches per month with an average duration of 4 hours if not treated
- Patient is otherwise neurologically and physically healthy on a pre-trial exam.
Key exclusion criteria (6 listed)
- Any other type of chronic headache (besides migraine) from section 2 to 13 of the International Headache Society classification or headache resulting directly resulting some other factor (except for medication overuse)
- Onset of migraine after age 50
- Use of an anticonvulsant drug in the month prior to trial entry
- Use of an antidepressant unless dose has been used at a stable dose for >=3 months
- Use of migraine prevention medicine in the 3 months prior to trial entry unless the drug has been used for at least 3 months and used at a stable dose for at least a month
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 migraine days, migraine periods, and migraine attacks compared between the topiramate group and placebo group at the last month of the baseline phase and the last month of the placebo-controlled phase
1 secondary outcome
Health-related quality of life as recorded in patient questionnaires (MIDAS, HIT-6, MSQ) over 16 double-blind weeks; Patient's satisfaction with the effectiveness and safety of topiramate; Safety
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 1 Feb 2011.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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 Pharmaceutica N.V. Clinical Trial study director
Janssen Pharmaceutica N.V.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topiramate in people with Migraine, run by Janssen Pharmaceutica N.V., Belgium.
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 6 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 1 Feb 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 migraine days, migraine periods, and migraine attacks compared between the topiramate group and placebo group at the last month of the baseline phase and the last month of the placebo-controlled phase. 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 1 Feb 2011.