Clinical trial NCT00216619: The Prolonged Use of Topiramate for Preventing Migraine Headaches
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: chronic migraine
Topiramate
migraine
headache
chronic headache
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 834
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
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
timeFrame: Last 4 weeks of Open Label (OL) Phase and Double Blind (DB) Phase
Secondary outcomes:
measure: Patient's Satisfaction
timeFrame: Visit 6
measure: Health related quality of life as recorded in patient questionnaires (MIDAS and SF-12)
timeFrame: Visit 2, Visit 6, Visit 10
measure: Health related quality of life as recorded in patient questionnaire (HIT-6)
timeFrame: Visit 2, Visit 4, Visit 6, Visit 8, Visit 10
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Antwerpen
country: Belgium
city: Charleroi
country: Belgium
city: Leuven
country: Belgium
city: Liÿge
country: Belgium
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sofia
country: Bulgaria
city: Hradec Nad Svitavou
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha
country: Czech Republic
city: Aabenraa
country: Denmark
city: Esbjerg
country: Denmark
city: Glostrup
country: Denmark
city: Kÿbenhavn K
country: Denmark
city: Odense
country: Denmark
city: Colombes Cedex
country: France
city: Lille Cedex
country: France
city: Nice
country: France
city: Paris Cedex 10
country: France
city: Paris
country: France
city: Rouen
country: France
city: Voiron
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: München
country: Germany
city: Mÿnster
country: Germany
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Budapest Na
country: Hungary
city: Budapest
country: Hungary
city: Miskolc
country: Hungary
city: Szeged Na
country: Hungary
city: Cork
country: Ireland
city: Dublin
country: Ireland
city: Bodø
country: Norway
city: Oslo
country: Norway
city: Trondheim
country: Norway
city: Gdansk
country: Poland
city: Krakow Malopolska
country: Poland
city: Lodz
country: Poland
city: Mosina Poland
country: Poland
city: Poznan Poland
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Moscow
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Riyadh
country: Saudi Arabia
city: Ljubljana
country: Slovenia
city: Maribor
country: Slovenia
city: Madrid
country: Spain
city: Biel-Bienne
country: Switzerland
city: St Gallen
country: Switzerland
city: Zurich
country: Switzerland
city: Bursa
country: Turkey
city: Istanbul
country: Turkey
city: Brighton
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Helensburgh
country: United Kingdom
city: Leicester
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Northampton
country: United Kingdom
city: Stoke On Trent
country: United Kingdom
city: Sunderland
country: United Kingdom
city: Surrey
country: United Kingdom
city: York
country: United Kingdom
Study officials:
affiliation: Janssen Pharmaceutica N.V.
name: Janssen Pharmaceutica N.V. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.