Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine - Full Text View

Sponsored by:	Lotus Pharmaceutical
Information provided by:	Lotus Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00334178

Purpose

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.

Condition	Intervention	Phase
Migraine With Aura Migraine Without Aura	Drug: Laxymig ER (drug)	Phase III

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Lotus Pharmaceutical:

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

Enrollment:	74
Study Start Date:	November 2004
Study Completion Date:	September 2006

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).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334178

Locations

Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
SinLau Christian Hospital
Tainan, Taiwan
Chinese Medical University Hospital
Taichung, Taiwan
Changhua Christian Hospital
Changhua, Taiwan
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung, Taiwan
Chang-Gung Memorial Hospital
LinKou, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112

Sponsors and Collaborators

Lotus Pharmaceutical

Investigators

Principal Investigator:

Shuu-Jiun Wang, MD

Taipei Veterans General Hospital,Taiwan

More Information

Study ID Numbers:	LAXY-P001-R-2003
Study First Received:	June 5, 2006
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00334178
Health Authority:	Taiwan: Department of Health

Keywords provided by Lotus Pharmaceutical:

Migraine
Migraine prophylaxis

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary

Migraine with Aura
Brain Diseases
Headache Disorders
Migraine without Aura

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009