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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Migraine With Aura, Migraine Without Aura

Intervention / Treatment
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* Drug: Laxymig ER (drug)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Laxymig ER (drug)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in the frequency of migraine attacks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Migraine prophylaxis