The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine

NCT00216606 | Completed Phase 3

• 1 other identifier: CR003928
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of individualized doses (50 to 200 milligrams) of topiramate tablets compared against placebo for the prevention of chronic migraine headaches over a period of 16 weeks.

Conditions

Migraine

Keywords

Chronic migraine; Migraine; Headache; Migraine headache; Topiramate

Outcome Measures

Primary Outcomes (1)

• Change in migraine days, migraine periods, and migraine attacks compared between the topiramate group and placebo group at the last month of the baseline phase and the last month of the placebo-controlled phase

Secondary Outcomes (1)

• Health-related quality of life as recorded in patient questionnaires (MIDAS, HIT-6, MSQ) over 16 double-blind weeks; Patient's satisfaction with the effectiveness and safety of topiramate; Safety

Interventions

topiramate DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of migraine for \>= 1 year
• Headache type meets HIS (International Headache Society) criteria for migraine
• History reflects "chronic" headache--an average of \>= 15 migraine days per month in the 3 months preceding trial entry
• History of chronic migraine for \>=1 year\>=15 headaches per month with an average duration of 4 hours if not treated
• Patient is otherwise neurologically and physically healthy on a pre-trial exam.

You may not qualify if:

• Any other type of chronic headache (besides migraine) from section 2 to 13 of the International Headache Society classification or headache resulting directly resulting some other factor (except for medication overuse)
• Onset of migraine after age 50
• Use of an anticonvulsant drug in the month prior to trial entry
• Use of an antidepressant unless dose has been used at a stable dose for \>=3 months
• Use of migraine prevention medicine in the 3 months prior to trial entry unless the drug has been used for at least 3 months and used at a stable dose for at least a month
• Use of a carbonic anhydrase inhibitor such as acetazolamide (used to treat high blood pressure, glaucoma and seizures) or triamterene (a "water pill" for swelling and high blood pressure).

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: December 1, 2003
• Study Completion: July 1, 2005
• Last Updated: February 1, 2011

Record last verified: 2011-01