The Prolonged Use of Topiramate for Preventing Migraine Headaches

NCT ID: NCT00216619

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 834 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2006-08-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Open Label Phase

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

Group Type: EXPERIMENTAL

Topiramate

Intervention Type: DRUG

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.

Double Blind and Roll Out Phase

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).

Group Type: EXPERIMENTAL

Topiramate

Intervention Type: DRUG

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 - Placebo

Intervention Type: DRUG

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)

Interventions

Topiramate

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.

Intervention Type: DRUG

Topiramate - Placebo

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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
• Patient had a history of severe drug allergy or hypersensitivity
• Patient overused analgesics, opiates, ergots and/or triptans
• Patient had been using topiramate regularly

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V.

Locations

Innsbruck, , Austria

Linz, , Austria

Antwerp, , Belgium

Charleroi, , Belgium

Leuven, , Belgium

Liÿge, , Belgium

Pleven, , Bulgaria

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Hradec nad Svitavou, , Czechia

Prague, , Czechia

Aabenraa, , Denmark

Esbjerg, , Denmark

Glostrup Municipality, , Denmark

Kÿbenhavn K, , Denmark

Odense, , Denmark

Colombes, , France

Lille, , France

Nice, , France

Paris, , France

Rouen, , France

Voiron, , France

Berlin, , Germany

Essen, , Germany

München, , Germany

Mÿnster, , Germany

Athens, , Greece

Thessaloniki, , Greece

Budapest, , Hungary

Budapest Na, , Hungary

Miskolc, , Hungary

Szeged Na, , Hungary

Cork, , Ireland

Dublin, , Ireland

Bodø, , Norway

Oslo, , Norway

Trondheim, , Norway

Gdansk, , Poland

Krakow Malopolska, , Poland

Lodz, , Poland

Mosina Poland, , Poland

Poznan, , Poland

Poznan Poland, , Poland

Warsaw, , Poland

Coimbra, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Moscow, , Russia

Saint Petersburg, , Russia

Riyadh, , Saudi Arabia

Ljubljana, , Slovenia

Maribor, , Slovenia

Madrid, , Spain

Biel/Bienne, , Switzerland

Sankt Gallen, , Switzerland

Zurich, , Switzerland

Bursa, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Brighton, , United Kingdom

Glasgow, , United Kingdom

Helensburgh, , United Kingdom

Leicester, , United Kingdom

Newcastle upon Tyne, , United Kingdom

Northampton, , United Kingdom

Stoke-on-Trent, , United Kingdom

Sunderland, , United Kingdom

Surrey, , United Kingdom

York, , United Kingdom

Countries

Austria; Belgium; Bulgaria; Czechia; Denmark; France; Germany; Greece; Hungary; Ireland; Norway; Poland; Portugal; Russia; Saudi Arabia; Slovenia; Spain; Switzerland; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: RESULT

PMID: 17988947 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=387&filename=CR003931_CSR.pdf

A double-blind, randomised, placebo-controlled, multicentre study to investigate the efficacy and tolerability of topiramate in prolonged migraine prevention.

Other Identifiers

2005-000321-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TOPMAT-MIG-303

Identifier Type: OTHER

Identifier Source: secondary_id

CR003931

Identifier Type: -

Identifier Source: org_study_id