Clinical Trial: Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief 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.
Detailed 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.
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).
Sponsor: Lotus Pharmaceutical
Current Primary Outcome: change from baseline in the frequency of migraine attacks
Original Primary Outcome: Same as current
Current Secondary Outcome:
- change from baseline in 4-week in migraine periods of week 9 to 12;
- change from baseline in 4-week in migraine days of week 9 to 12;
- the proportion of subjects with a reduction of 50% or more in 4-week migraine frequencies;
- the proportion of subjects with a reduction of 50% or more in 4-week migraine periods;
- the proportion of subjects with a reduction of 50% or more in 4-week migraine days
- the average symptomatic medications usage
Original Secondary Outcome: Same as current
Information By: Lotus Pharmaceutical
Dates:
Date Received: June 5, 2006
Date Started: November 2004
Date Completion:
Last Updated: September 6, 2007
Last Verified: September 2007