migraine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18–65 years old; 2. migraine with or without aura (International Classification of Headache Disorders [ICHD]-II code 1.2.1 or 1.1); 3. the first migraine attack was before 50 years old; 4. The disease course longer than 1 year; 5. at least 2 attacks per month.
Exclusion criteria
Exclusion criteria: 1. use of a preventive antimigraine treatment such as beta blockers, calcium channel blockers, antiepileptic drugs, antidepressants and 5-HT receptor blockers in the previous 3 months; 2. failure on =3 well-conducted preventive drug treatments; 3. medication overuse headache (ICHD-II 8.2)(>10 days per month usage of preventive medication for migraine attacks); 4. alcohol abuse and/or other drug overuse; 5. severe neurological or psychiatric disorders; 6. Severe primary systemic disorders including heart, brain, liver, kidney, hematopoietic system; 7. Pregnant and lactating women; 8. Allergic to study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in monthly migraine days between the run-in month and the third month of treatment;percentage of of subjects having at least 50% reduction of monthly migraine days; | — |
Secondary
| Measure | Time frame |
|---|---|
| change in monthly migraine days between run-in and the average 3 months of treatment;change in monthly migraine attack frequency;change in mean headache severity per migraine day;change in monthly acute antimigrainedrug use;Change of the Migraine Disability Assessment questionnaire; | — |
Countries
China