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

Migraine Without Aura Clinical Trial

Official title:
A Multi-Center, Randomized, Parallel, Double-Blind, Placebo-Controlled Study in Evaluation the Efficacy and Safety of Laxymig® ER as Prophylactic Treatment in Patients With Migraine

Clinical Trial 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.

Clinical Trial Description

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.

Four weeks baseline, following with 12 weeks treatment phase. Subjects migraine are recorded by diary cards and re-evaluated by the investigator.

Subject will have visit every 4-week (+/- 7 days). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00334178
Study type Interventional
Source Lotus Pharmaceutical
Contact
Status Completed
Phase Phase 3
Start date November 2004
Completion date September 2006
View Details
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