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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laxymig ER (drug) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in the frequency of migraine attacks |
| Measure | Description | Time Frame |
|---|---|---|
| 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; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shuu-Jiun Wang, MD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhua Christian Hospital | Changhua | Taiwan | ||||
| Chung-Ho Memorial Hospital, Kaohsiung Medical University |
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| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| 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 |
| Kaohsiung City |
| Taiwan |
| Chang-Gung Memorial Hospital | Linkou District | Taiwan |
| Chinese Medical University Hospital | Taichung | Taiwan |
| SinLau Christian Hospital | Tainan | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Taipei Medical University Hospital | Taipei | Taiwan |
| D009422 | Nervous System Diseases |