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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00334178

Enrollment

Registered

2006-06-06

Start date

2004-11-30

Completion date

2006-09-30

Last updated

2007-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine With Aura, Migraine Without Aura

Keywords

Migraine, Migraine prophylaxis

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).

Interventions

DRUGLaxymig ER (drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
change from baseline in the frequency of migraine attacks	—

Secondary

Measure	Time frame
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;	—
change from baseline in 4-week in migraine periods of week 9 to 12;	—
the proportion of subjects with a reduction of 50% or more in 4-week migraine days	—
the average symptomatic medications usage	—
the proportion of subjects with a reduction of 50% or more in 4-week migraine periods;	—

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026