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