Trial | NCT00334178  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    74
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.
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).
Study Started
Nov 30
2004
Study Completion
Sep 30
2006
Last Update
Sep 10
2007
Estimate

Drug Laxymig ER (drug)

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
No Results Posted