A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine

NCT00253175 | Completed Phase 3

• 1 other identifier: CR005572
• Study Type: interventional
• Target: 211
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this study is to evaluate the effectiveness and safety of topiramate (an epilepsy medication) compared with placebo in the prevention of migraine.

Conditions

Vascular Headaches; Migraine

Keywords

topiramate; migraine headache; migraine prevention; migraine

Outcome Measures

Primary Outcomes (1)

• Reduction in the frequency of monthly migraine episodes during the entire double-blind treatment phase compared with the pretreatment phase.

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:

• Meet the criteria of the International Headache Society for the classification of migraine with or without aura (migraine symptoms)
• Diagnosis of migraine for at least 12 months prior to start of the study
• Have had an average of 3 to 8 migraine attacks per month for the 3 months prior to the start of the study
• Ability to recognize migraine headaches and to distinguish them from tension-type headaches or other types of head pain
• General good health

You may not qualify if:

• Patients who previously failed to respond to topiramate therapy for migraine prevention or who discontinued topiramate due to adverse events
• Patients who had onset of migraine after age 50
• Patients having more than 15 headache-days per month during the 3 months prior to start of the study, or during the baseline (pretreatment) period
• Patients who have cluster headaches or who have exclusively aura (migraine symptoms) without headache
• Female patients who are pregnant, nursing, or those not using adequate birth control, if capable of bearing children

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho-McNeil Neurologics, Inc.: collaborator

Related Publications (1)

• Silberstein SD, Hulihan J, Karim MR, Wu SC, Jordan D, Karvois D, Kamin M. Efficacy and tolerability of topiramate 200 mg/d in the prevention of migraine with/without aura in adults: a randomized, placebo-controlled, double-blind, 12-week pilot study. Clin Ther. 2006 Jul;28(7):1002-11. doi: 10.1016/j.clinthera.2006.07.003.

  PMID: 16990078 RESULT

MeSH Terms

Conditions

Vascular Headaches; Migraine Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Secondary; Headache Disorders; Vascular Diseases; Cardiovascular Diseases; Headache Disorders, Primary

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  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: November 10, 2005
• First Posted: November 15, 2005
• Study Start: October 1, 2000
• Study Completion: December 1, 2001
• Last Updated: April 28, 2010

Record last verified: 2010-04