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

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ClinicalTrials.gov Identifier: NCT00334178
Recruitment Status : Completed
First Posted : June 6, 2006
Last Update Posted : September 10, 2007
Sponsor:
Information provided by:
Lotus Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Migraine With Aura Migraine Without Aura Drug: Laxymig ER (drug) Phase 3

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  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2004
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources




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

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Veterans General Hospital
Taipei, Taiwan, 112
Taipei Medical University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Lotus Pharmaceutical
Investigators
Principal Investigator: Shuu-Jiun Wang, MD Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier: NCT00334178     History of Changes
Other Study ID Numbers: LAXY-P001-R-2003
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: September 10, 2007
Last Verified: September 2007

Keywords provided by Lotus Pharmaceutical:
Migraine
Migraine prophylaxis

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