MigrainePhase 3PROMPTNCT00216619
The Prolonged Use of Topiramate for Preventing Migraine Headaches
A Phase 3 study testing Topiramate in people with Migraine, run by Janssen Pharmaceutica N.V., Belgium at 68 sites in 20 countries.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 834 participants
- Where
- 68 sitesin 20 countries
- Study dates
- Nov 2003to Aug 2006
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established history of migraine for at least one year;
- Migraine meets HIS (International Headache Society) criteria
- An average of at least 4 monthly migraine days during the 3 months preceding trial entry
- Capable of keeping trial records; Exclusion Criteria:
- Patient used migraine prophylactic medication in the month prior to trial entry (flunarizine: 3 months prior to entry)
- Patient had failed (lack of efficacy) more than two adequate previous regimens of migraine prophylactic medications
Show all 9Show fewer
- Patient had a history of severe drug allergy or hypersensitivity
- Patient overused analgesics, opiates, ergots and/or triptans
- Patient had been using topiramate regularly
Who cannot join
None listed.
Trial locations and contacts
68 sites in 20 countries.
68 sites in 20 countries
United Kingdom10 sites
Study site
Brighton
Study site
Glasgow
Study site
Helensburgh
Study site
Leicester
Study site
Newcastle upon Tyne
Study site
Northampton
Study site
Stoke-on-Trent
Study site
Sunderland
Study site
Surrey
Study site
York
Poland7 sites
Study site
Gdansk
Study site
Krakow Malopolska
Study site
Lodz
Study site
Mosina Poland
Study site
Poznan
Study site
Poznan Poland
Study site
Warsaw
France6 sites
Study site
Colombes
Study site
Lille
Study site
Nice
Study site
Paris
Study site
Rouen
Study site
Voiron
Denmark5 sites
Study site
Aabenraa
Study site
Esbjerg
Study site
Glostrup Municipality
Study site
Kÿbenhavn K
Study site
Odense
Belgium4 sites
Study site
Antwerp
Study site
Charleroi
Study site
Leuven
Study site
Liÿge
Germany4 sites
Study site
Berlin
Study site
Essen
Study site
München
Study site
Mÿnster
Hungary4 sites
Study site
Budapest
Study site
Budapest Na
Study site
Miskolc
Study site
Szeged Na
Switzerland3 sites
Study site
Biel/Bienne
Study site
Sankt Gallen
Study site
Zurich
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention
The purpose of this study is to evaluate the safety and effectiveness (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks.
Read the detailed description
Previous studies have shown that topiramate is effective in preventing migraine headaches. This study will start with a 4-week baseline period in which no treatment is given, followed by a 26-week period in which each patient's dose is adjusted and then kept stable for 4 weeks. The 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 randomized to receive topiramate will remain on that dose. The comparison phase of the study is a 26-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 during the last 4 weeks of the double-blind phase, relative to the last 4 weeks of the open-label phase, is reduced more in the topiramate group than the placebo group. During open-label (26-weeks) and double-blind phase (26-weeks), patients receiving topiramate will take 25 milligrams to 100 milligrams daily by mouth; increased by 25 milligrams per day once weekly; dose cannot exceed 200 milligrams per day and must be stable for the last 4 weeks.
- Conditions
- Migraine
- Being tested
- Topiramate, Topiramate - Placebo
- Keywords
- chronic migraine, Topiramate, migraine, headache, chronic headache
- Medical subject headings
- Migraine Disorders, Headache, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
topiramate treatment started with one tablet per day, taken in the evening, for the first 7 days of the OL phase. Each tablet contained 25 mg topiramate. After one week, the dose was raised to two tablets per day: one tablet was taken in the morning, the other in the evening.
Topiramate - PlaceboDrug
the trial medication consisted of topiramate 25 mg tablets or matching placebo tablets which were identical in appearance, taste and smell. DB randomisation phase (after the 26-weeks OL phase) were randomly allocated (1:1) to one of the two treatment groups (topiramate or placebo). The randomisation took place at Visit 6 (Week 26)
| Study group | Role | What they receive |
|---|---|---|
| Open Label Phase | Experimental | Topiramate treatment started with one tablet per day, taken in the evening, for the first 7 days of the OL phase. Each tablet contained 25 mg topiramate. After one week, the dose was raised to two tablets per day: one tablet was taken in the morning, the other in the evening. Until Week 26 Receives: Drug: Topiramate |
| Double Blind and Roll Out Phase | Experimental | the trial medication consisted of topiramate 25 mg tablets or matching placebo tablets which were identical in appearance, taste and smell. DB randomisation phase (after the 26-weeks OL phase) were randomly allocated (1:1) to one of the two treatment groups (topiramate or placebo). The randomisation took place at Visit 6 (Week 26). Receives: Drug: Topiramate; Drug: Topiramate - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in migraine days compared between the topiramate group and placebo group at the last 4 weeks of the open-label phase and the final 4 weeks of the placebo-controlled phase
Measured: Last 4 weeks of Open Label (OL) Phase and Double Blind (DB) Phase
Secondary outcomes (3)
Patient's Satisfaction
at the end of the OL Phase and at the end of the DB Phase
Measured: Visit 6
Health related quality of life as recorded in patient questionnaires (MIDAS and SF-12)
At the start of the OL Phase; at the end of the of the OL Phase and at the end of the DB Phase
Measured: Visit 2, Visit 6, Visit 10
Health related quality of life as recorded in patient questionnaire (HIT-6)
HIT-6 extra questioned at Week 8 and Week 34
Measured: Visit 2, Visit 4, Visit 6, Visit 8, Visit 10
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 startNov 2003
- Study completionAug 2006
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica N.V. Clinical Trial, Study director, Janssen Pharmaceutica N.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216619
- Sponsor's protocol ID
- CR003931
- Other IDs
- 2005-000321-29, TOPMAT-MIG-303, 2005
- Acronym
- PROMPT
- Status last verified
- Jul 2014
- First submitted
- 13 Sep 2005
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Diener HC, Agosti R, Allais G, Bergmans P, Bussone G, Davies B, Ertas M, Lanteri-Minet M, Reuter U, Sanchez Del Rio M, Schoenen J, Schwalen S, van Oene J; TOPMAT-MIG-303 Investigators Group. Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2007 Dec;6(12):1054-62. doi: 10.1016/S1474-4422(07)70272-7. Epub 2007 Nov 7.
PubMed 17988947
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention
- ClinicalTrials.gov ID
- NCT00216619
- Acronym / sponsor ID
- PROMPT / CR003931
- Conditions
- Migraine
- Keywords
- chronic migraine, Topiramate, migraine, headache, chronic headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Aug 2006 (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 (beyond 6 months) of individualized doses (100 to 200 milligrams) of topiramate for the prevention of migraine headaches over a period of 26 weeks.
Detailed description
Previous studies have shown that topiramate is effective in preventing migraine headaches. This study will start with a 4-week baseline period in which no treatment is given, followed by a 26-week period in which each patient's dose is adjusted and then kept stable for 4 weeks. The 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 randomized to receive topiramate will remain on that dose. The comparison phase of the study is a 26-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 during the last 4 weeks of the double-blind phase, relative to the last 4 weeks of the open-label phase, is reduced more in the topiramate group than the placebo group. During open-label (26-weeks) and double-blind phase (26-weeks), patients receiving topiramate will take 25 milligrams to 100 milligrams daily by mouth; increased by 25 milligrams per day once weekly; dose cannot exceed 200 milligrams per day and must be stable for the last 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Label Phase | Experimental | Drug: TopiramateTopiramate treatment started with one tablet per day, taken in the evening, for the first 7 days of the OL phase. Each tablet contained 25 mg topiramate. After one week, the dose was raised to two tablets per day: one tablet was taken in the morning, the other in the evening. Until Week 26 |
| Double Blind and Roll Out Phase | Experimental | Drug: Topiramate, Drug: Topiramate - Placebothe trial medication consisted of topiramate 25 mg tablets or matching placebo tablets which were identical in appearance, taste and smell. DB randomisation phase (after the 26-weeks OL phase) were randomly allocated (1:1) to one of the two treatment groups (topiramate or placebo). The randomisation took place at Visit 6 (Week 26). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Established history of migraine for at least one year;
- Migraine meets HIS (International Headache Society) criteria
- An average of at least 4 monthly migraine days during the 3 months preceding trial entry
- Capable of keeping trial records; Exclusion Criteria:
- Patient used migraine prophylactic medication in the month prior to trial entry (flunarizine: 3 months prior to entry)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Topiramatetopiramate treatment started with one tablet per day, taken in the evening, for the first 7 days of the OL phase. Each tablet contained 25 mg topiramate. After one week, the dose was raised to two tablets per day: one tablet was taken in the morning, the other in the evening. | Drug | Double Blind and Roll Out Phase, Open Label Phase |
| Topiramate - Placebothe trial medication consisted of topiramate 25 mg tablets or matching placebo tablets which were identical in appearance, taste and smell. DB randomisation phase (after the 26-weeks OL phase) were randomly allocated (1:1) to one of the two treatment groups (topiramate or placebo). The randomisation took place at Visit 6 (Week 26) | Drug | Double Blind and Roll Out Phase |
Primary outcome
Change in migraine days compared between the topiramate group and placebo group at the last 4 weeks of the open-label phase and the final 4 weeks of the placebo-controlled phase
Time frame: Last 4 weeks of Open Label (OL) Phase and Double Blind (DB) Phase
3 secondary outcomes
Patient's Satisfaction
Time frame: Visit 6
Health related quality of life as recorded in patient questionnaires (MIDAS and SF-12)
Time frame: Visit 2, Visit 6, Visit 10
Health related quality of life as recorded in patient questionnaire (HIT-6)
Time frame: Visit 2, Visit 4, Visit 6, Visit 8, Visit 10
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 2 Jul 2014.
- Results publication: PubMed 17988947Diener HC, Agosti R, Allais G, Bergmans P, Bussone G, Davies B, Ertas M, Lanteri-Minet M, Reuter U, Sanchez Del Rio M, Schoenen J, Schwalen S, van Oene J; TOPMAT-MIG-303 Investigators Group. Cessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2007 Dec;6(12):1054-62. doi: 10.1016/S1474-4422(07)70272-7. Epub 2007 Nov 7.
- A double-blind, randomised, placebo-controlled, multicentre study to investigate the efficacy and tolerability of topiramate in prolonged migraine prevention.Link 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 Pharmaceutica N.V. Clinical Trial study director
Janssen Pharmaceutica N.V.
68 sites in 20 countries: see every site and its status.
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 at 68 sites in 20 countries.
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 9 inclusion and 0 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 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United Kingdom, Poland, France, Denmark, Belgium and 15 more countries. 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 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 compared between the topiramate group and placebo group at the last 4 weeks of the open-label phase and the final 4 weeks of the placebo-controlled phase (time frame: Last 4 weeks of Open Label (OL) Phase and Double Blind (DB) 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 NCT00216619, 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 2 Jul 2014.