Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Laxymig® ER compared with placebo in prophylactic monotherapy treatment of migraine headache.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lotus Pharmaceutical

Criteria

Inclusion Criteria:

• Clinical diagnosis of migraine with or without aura (typical aura with migraine headache)

• Subjects who had an average of two or more migraine frequencies per month during the 3 months before screening

Exclusion Criteria:

• Female subjects who are pregnant, lactating

• Chronic daily headache

• Previous treatment with three or more migraine prophylaxis medications failed

• Subjects with hepatic disease whose liver enzymes are over 2 times of upper limit of reference or significant dysfunction

• Coexisting medical, neurological, or psychiatric disorder that may hinder the study according to the investigator's judgment