Back to resultsEvaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
Primary Purpose
Migraine With Aura, Migraine Without Aura
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Laxymig ER (drug)
Sponsored by
About this trial
This is an interventional prevention trial for Migraine With Aura focused on measuring Migraine, Migraine prophylaxis
Eligibility 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
Sites / Locations
- Changhua Christian Hospital
- Chung-Ho Memorial Hospital, Kaohsiung Medical University
- Chang-Gung Memorial Hospital
- Chinese Medical University Hospital
- SinLau Christian Hospital
- Taipei Veterans General Hospital
- Taipei Medical University Hospital
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00334178
Brief Title
Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
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 Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lotus Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Migraine Without Aura
Keywords
Migraine, Migraine prophylaxis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Laxymig ER (drug)
Primary Outcome Measure Information:
Title
change from baseline in the frequency of migraine attacks
Secondary Outcome Measure Information:
Title
change from baseline in 4-week in migraine periods of week 9 to 12;
Title
change from baseline in 4-week in migraine days of week 9 to 12;
Title
the proportion of subjects with a reduction of 50% or more in 4-week migraine frequencies;
Title
the proportion of subjects with a reduction of 50% or more in 4-week migraine periods;
Title
the proportion of subjects with a reduction of 50% or more in 4-week migraine days
Title
the average symptomatic medications usage
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuu-Jiun Wang, MD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Chung-Ho Memorial Hospital, Kaohsiung Medical University
City
Kaohsiung
Country
Taiwan
Facility Name
Chang-Gung Memorial Hospital
City
LinKou
Country
Taiwan
Facility Name
Chinese Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
SinLau Christian Hospital
City
Tainan
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
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