Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
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
1 other identifier
interventional
74
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2004
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 5, 2006
CompletedFirst Posted
Study publicly available on registry
June 6, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedSeptember 10, 2007
September 1, 2007
June 5, 2006
September 6, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from baseline in the frequency of migraine attacks
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuu-Jiun Wang, MD
Taipei Veterans General Hospital, Taiwan
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 5, 2006
First Posted
June 6, 2006
Study Start
November 1, 2004
Study Completion
September 1, 2006
Last Updated
September 10, 2007
Record last verified: 2007-09