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

Migraine Without Aura Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334178
• Other study ID #: LAXY-P001-R-2003
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2006
• Last updated: September 6, 2007
• Start date: November 2004
• Est. completion date: September 2006

Study information

• Verified date: September 2007
• Source: Lotus Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura
• Migraine Without Aura

Intervention

Drug:
• Laxymig ER (drug)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Lotus Pharmaceutical

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in the frequency of migraine attacks
Secondary	change from baseline in 4-week in migraine periods of week 9 to 12;
Secondary	change from baseline in 4-week in migraine days of week 9 to 12;
Secondary	the proportion of subjects with a reduction of 50% or more in 4-week migraine frequencies;
Secondary	the proportion of subjects with a reduction of 50% or more in 4-week migraine periods;
Secondary	the proportion of subjects with a reduction of 50% or more in 4-week migraine days
Secondary	the average symptomatic medications usage