Status:
COMPLETED
Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
Lead Sponsor:
Lotus Pharmaceutical
Conditions:
Migraine With Aura
Migraine Without Aura
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00334178
Start Date
November 1 2004
End Date
September 1 2006
Last Update
September 10 2007
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Changhua Christian Hospital
Changhua, Taiwan
2
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, Taiwan
3
Chang-Gung Memorial Hospital
Linkou District, Taiwan
4
Chinese Medical University Hospital
Taichung, Taiwan