Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Lotus Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00334178
First received: June 5, 2006
Last updated: September 6, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Migraine With Aura
Migraine Without Aura
Drug: Laxymig ER (drug)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Lotus Pharmaceutical:

Primary Outcome Measures:
  • change from baseline in the frequency of migraine attacks

Secondary Outcome Measures:
  • 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

Enrollment: 74
Study Start Date: November 2004
Study Completion Date: September 2006
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334178

Locations
Taiwan
Changhua Christian Hospital
Changhua, Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung, Taiwan
Chang-Gung Memorial Hospital
LinKou, Taiwan
Chinese Medical University Hospital
Taichung, Taiwan
SinLau Christian Hospital
Tainan, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Lotus Pharmaceutical
Investigators
Principal Investigator: Shuu-Jiun Wang, MD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00334178     History of Changes
Other Study ID Numbers: LAXY-P001-R-2003
Study First Received: June 5, 2006
Last Updated: September 6, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by Lotus Pharmaceutical:
Migraine
Migraine prophylaxis

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014