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NCT Number: NCT00334178

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

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.

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Key information

Conditions

Migraine With Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Migraine Without Aura Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Changhua Christian Hospital, Changhua, Taiwan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laxymig ER (drug)

Drug

Primary outcomes

  1. change from baseline in the frequency of migraine attacks

Secondary outcomes

  1. change from baseline in 4-week in migraine periods of week 9 to 12;

  2. change from baseline in 4-week in migraine days of week 9 to 12;

  3. the proportion of subjects with a reduction of 50% or more in 4-week migraine frequencies;

  4. the proportion of subjects with a reduction of 50% or more in 4-week migraine periods;

  5. the proportion of subjects with a reduction of 50% or more in 4-week migraine days

  6. the average symptomatic medications usage

Sponsors and collaborators

Lead sponsor

Lotus Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Jun 6, 2006
Registry last updated
Sep 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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