The Prolonged Use of Topiramate for Preventing Migraine Headaches
PROMPT
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention
3 other identifiers
interventional
834
20 countries
68
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2003
Typical duration for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedJuly 2, 2014
July 1, 2014
September 13, 2005
July 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Last 4 weeks of Open Label (OL) Phase and Double Blind (DB) Phase
Secondary Outcomes (3)
Patient's Satisfaction
Visit 6
Health related quality of life as recorded in patient questionnaires (MIDAS and SF-12)
Visit 2, Visit 6, Visit 10
Health related quality of life as recorded in patient questionnaire (HIT-6)
Visit 2, Visit 4, Visit 6, Visit 8, Visit 10
Study Arms (2)
Open Label Phase
EXPERIMENTALTopiramate 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
EXPERIMENTALthe 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).
Interventions
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.
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Patient had a history of severe drug allergy or hypersensitivity
- Patient overused analgesics, opiates, ergots and/or triptans
- Patient had been using topiramate regularly
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
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Innsbruck, Austria
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Linz, Austria
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Antwerp, Belgium
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Charleroi, Belgium
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Leuven, Belgium
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Liÿge, Belgium
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Hradec nad Svitavou, Czechia
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Prague, Czechia
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Aabenraa, Denmark
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Esbjerg, Denmark
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Glostrup Municipality, Denmark
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Kÿbenhavn K, Denmark
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Odense, Denmark
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Colombes, France
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Lille, France
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Nice, France
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Paris, France
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Rouen, France
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Voiron, France
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Berlin, Germany
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Essen, Germany
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München, Germany
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Mÿnster, Germany
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Athens, Greece
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Thessaloniki, Greece
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Budapest, Hungary
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Budapest Na, Hungary
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Miskolc, Hungary
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Szeged Na, Hungary
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Cork, Ireland
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Dublin, Ireland
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Bodø, Norway
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Oslo, Norway
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Trondheim, Norway
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Gdansk, Poland
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Krakow Malopolska, Poland
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Lodz, Poland
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Mosina Poland, Poland
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Poznan, Poland
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Poznan Poland, Poland
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Warsaw, Poland
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Moscow, Russia
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Saint Petersburg, Russia
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Riyadh, Saudi Arabia
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Ljubljana, Slovenia
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Maribor, Slovenia
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Madrid, Spain
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Biel/Bienne, Switzerland
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Sankt Gallen, Switzerland
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Zurich, Switzerland
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Bursa, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Brighton, United Kingdom
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Glasgow, United Kingdom
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Helensburgh, United Kingdom
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Leicester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Northampton, United Kingdom
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Stoke-on-Trent, United Kingdom
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Sunderland, United Kingdom
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Surrey, United Kingdom
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York, United Kingdom
Related Publications (1)
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.
PMID: 17988947RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V. Clinical Trial
Janssen Pharmaceutica N.V.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
November 1, 2003
Study Completion
August 1, 2006
Last Updated
July 2, 2014
Record last verified: 2014-07