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

Phase 3

Completed

• Conditions: Migraine With Aura; Migraine Without Aura

• Registration Number: NCT00334178
• Lead Sponsor: Lotus Pharmaceutical

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 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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-06-05
• Study First Submitted QC: 2006-06-05
• Study First Posted: 2006-06-06
• Study Completion: 2006-09
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-06
• Last Update Posted: 2007-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change from baseline in the frequency of migraine attacks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Chung-Ho Memorial Hospital, Kaohsiung Medical University; 🇨🇳 Kaohsiung, Taiwan

Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan

SinLau Christian Hospital; 🇨🇳 Tainan, Taiwan

Chinese Medical University Hospital; 🇨🇳 Taichung, Taiwan

Chang-Gung Memorial Hospital; 🇨🇳 LinKou, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan