An Open-label Study to Evaluate Topiramate Therapy in Migraine Patients, and Its Effects on Subject Responsiveness to Migraine Treatment With Triptans

NCT00261469 | Completed Phase 2

• 1 other identifier: CR005686
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate whether prophylactic use of topiramate (preventative use before a migraine attack) enhances the effectiveness of migraine treatment with triptans.

Conditions

Headache

Keywords

Migraine; Headache

Outcome Measures

Primary Outcomes (1)

• The proportion of migraine attacks that are pain-free two hours after triptan treatment, compared to baseline.

Secondary Outcomes (1)

• Pain relief at two hours after triptan treatment, compared to baseline; the proportion of migraine attacks that are pain-free 1 hour after triptan treatment, compared to baseline; adverse events

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:

• Subjects must have an established history consistent with migraine, with or without aura, confirming to International Headache Society (HIS) criteria for at least 6 months prior to study entry
• must be using a stable dose of triptan for migraine treatment for at least 3 migraine attacks per month
• must have failed \<=2 previous prophylactic medications due to lack of effectiveness
• must have had between 3 and 12 migraine periods and no more than 18 headache days (migraine and non-migraine) during the 6-week Prospective Baseline Period. (A headache day is defined as a calendar day which the subject experienced headache pain for at least 4 hours untreated, or 30 minutes duration treated)
• female subjects who are postmenopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 1.

You may not qualify if:

• Subjects with headaches other than migraine with and/or without aura
• onset of migraine after age 50
• overuse analgesics or specific medications for treatment of migraine attacks
• currently on a prophylactic medication for migraine
• history of an unstable medical condition within the past 2 years, malignancy within the past 5 years, major psychiatric disorder within the past 6 months, suicidal ideations or suicide attempt within the past 2 years or history of alcohol or drug abuse within the past 6 months

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

Related Links

• Prophylactic Topiramate and Response to Triptan Treatment for Acute Migraine

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Topiramate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 5, 2005
• Study Start: April 1, 2003
• Study Completion: November 1, 2004
• Last Updated: May 17, 2011

Record last verified: 2011-01