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

Lotus Pharmaceutical74 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Migraine With Aura Migraine Without Aura

Interventions

Laxymig ER (drug)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (7)

Changhua Christian Hospital

Changhua, Taiwan

Chung-Ho Memorial Hospital, Kaohsiung Medical University

Kaohsiung City, Taiwan

Chang-Gung Memorial Hospital

Linkou District, Taiwan

Chinese Medical University Hospital

Taichung, Taiwan

Outcomes

Primary Outcomes

change from baseline in the frequency of migraine attacks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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