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Keep this study
Lead
Lotus Pharmaceutical
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).
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
