Clinical trial NCT00334178: Evaluation of the Efficacy and Safety of Laxymig® as Prophylactic Treatment in Patients With Migraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine With Aura
Migraine Without Aura
Keywords: Migraine
Migraine prophylaxis
Lead sponsor: Lotus Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: change from baseline in the frequency of migraine attacks
Secondary outcomes:
measure: change from baseline in 4-week in migraine periods of week 9 to 12;
measure: change from baseline in 4-week in migraine days of week 9 to 12;
measure: the proportion of subjects with a reduction of 50% or more in 4-week migraine frequencies;
measure: the proportion of subjects with a reduction of 50% or more in 4-week migraine periods;
measure: the proportion of subjects with a reduction of 50% or more in 4-week migraine days
measure: the average symptomatic medications usage
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University
city: LinKou
country: Taiwan
facility: Chang-Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Chinese Medical University Hospital
city: Tainan
country: Taiwan
facility: SinLau Christian Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Shuu-Jiun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: