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

September 6, 2007 updated by: Lotus Pharmaceutical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan
        • Chung-Ho Memorial Hospital, Kaohsiung Medical University
      • LinKou, Taiwan
        • Chang-Gung Memorial Hospital
      • Taichung, Taiwan
        • Chinese Medical University Hospital
      • Tainan, Taiwan
        • SinLau Christian Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan
        • Taipei Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
change from baseline in the frequency of migraine attacks

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lotus Pharmaceutical

Investigators

  • Principal Investigator: Shuu-Jiun Wang, MD, Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

June 5, 2006

First Submitted That Met QC Criteria

June 5, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

September 10, 2007

Last Update Submitted That Met QC Criteria

September 6, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAXY-P001-R-2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine Without Aura

Clinical Trials on Laxymig ER (drug)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe