Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
NCT ID: NCT00334178
Last Updated: 2007-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
74 participants
INTERVENTIONAL
2004-11-30
2006-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Interventions
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Laxymig ER (drug)
Eligibility Criteria
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Inclusion Criteria
* Subjects who had an average of two or more migraine frequencies per month during the 3 months before screening
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Lotus Pharmaceutical
INDUSTRY
Principal Investigators
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Shuu-Jiun Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Locations
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Changhua Christian Hospital
Changhua, , Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, , Taiwan
Chang-Gung Memorial Hospital
Linkou District, , Taiwan
Chinese Medical University Hospital
Taichung, , Taiwan
SinLau Christian Hospital
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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LAXY-P001-R-2003
Identifier Type: -
Identifier Source: org_study_id