An Efficacy and Tolerability Study of Topiramate in Participants With Migraine

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the adequacy (reasonably good) of topiramate therapy (medicine or medical care given to a participant for a disease or condition) in prevention of migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea) by comparing standard titration (slow increase in drug dosage, guided by patient's responses) therapy to slow titration therapy and slow titration therapy boosted by the concurrent use of propranolol in participants with migraine with or without aura (having to do with the ear) for more than or equal to 2 attacks per month.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Propranolol; Topiramate

Criteria

Inclusion Criteria:

• Particpants who have signed the consent form

• Participants who have 3 to 14 episodes of migraine a month

• Participants whose duration of migraine is at least 6 months

• Participants who can read and understand the migraine disability assessment (MIDAS) questionnaire

• Female Participants who are using an appropriate contraception method or have negative pregnancy test results

Exclusion Criteria:

• Participants whose headache attacks at Baseline or during the study period are assumed to be caused by a drug withdrawal syndrome

• Participants whose migraine has appeared first at over 50 years of age

• Participants who have taken anticonvulsants (valproic acid, gabapentin), beta adrenergic blockers (propranolol) and calcium antagonists (sibelium, verapamil, diltiazem) or topiramate or propranolol within the last 8 weeks

• Participants with progressive neurological (pertaining to the nervous system) disorder

• Participants with severe renal (pertaining to the kidneys) disorder, hepatic (pertaining to the liver) failure or diabetes (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects) or with the history of renal calculus