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The Prolonged Use of Topiramate for Preventing Migraine Headaches

Information source: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine

Intervention: Topiramate (Drug); Topiramate - Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen Pharmaceutica N.V., Belgium

Official(s) and/or principal investigator(s):
Janssen Pharmaceutica N.V. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica N.V.

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.

Clinical Details

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Investigate the Efficacy and Tolerability of Topiramate in Prolonged Migraine Prevention

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

Patient's Satisfaction

Health related quality of life as recorded in patient questionnaires (MIDAS and SF-12)

Health related quality of life as recorded in patient questionnaire (HIT-6)

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Innsbruck, Austria

Linz, Austria

Antwerpen, Belgium

Charleroi, Belgium

Leuven, Belgium

Liÿge, Belgium

Pleven, Bulgaria

Plovdiv, Bulgaria

Sofia, Bulgaria

Hradec Nad Svitavou, Czech Republic

Praha 2, Czech Republic

Praha, Czech Republic

Aabenraa, Denmark

Esbjerg, Denmark

Glostrup, Denmark

Kÿbenhavn K, Denmark

Odense, Denmark

Colombes Cedex, France

Lille Cedex, France

Nice, France

Paris Cedex 10, France

Paris, France

Rouen, France

Voiron, France

Berlin, Germany

Essen, Germany

München, Germany

Mÿnster, Germany

Athens, Greece

Thessaloniki, Greece

Budapest Na, Hungary

Budapest, 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, Poland

Poznan, Poland

Warszawa, Poland

Coimbra, Portugal

Lisboa, Portugal

Porto, Portugal

Moscow, Russian Federation

St-Petersburg, Russian Federation

Riyadh, Saudi Arabia

Ljubljana, Slovenia

Maribor, Slovenia

Madrid, Spain

Biel-Bienne, Switzerland

St Gallen, Switzerland

Zurich, Switzerland

Bursa, Turkey

Istanbul, Turkey

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

Additional Information

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

Starting date: November 2003
Last updated: July 1, 2014

Page last updated: August 23, 2015

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