Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine

Lotus Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Migraine With Aura

Migraine Without Aura

Treatments

Drug: Laxymig ER (drug)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00334178

LAXY-P001-R-2003

Details and patient eligibility

About

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.

Full 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).

Enrollment

74 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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