Migraine
Conditions
Sponsors
Otsuka Pharmaceutical Co., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition [beta version] criteria) or clinical judgment suggests a migraine diagnosis 2. Patient fulfills the criteria for Chronic migraine in baseline information collected during the 28 day screening period 3. Not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent. 4. Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator
Exclusion criteria
Exclusion criteria: 1. Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses 2. Patient suffers from unremitting headaches, defined as having headaches for more than 80% of the time that he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if the patient has headaches 80% or less of the time they are awake on most days. 3. Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Mean change from baseline in the monthly (28 day) average number of headache days of at least moderate severity during the 12-week period after the first dose of Investigational Medicinal Product(IMP) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1. Mean change from baseline in the monthly average number of migraine days during the 12-week period after the first dose of IMP 2. Proportion of subjects reaching at least 50% reduction in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of IMP 3. Mean change from baseline in the monthly average number of days with use of any acute headache medications during the 12-week period after the first dose of IMP 4. Mean change from baseline in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of IMP in subjects not receiving concomitant preventive migraine medications 5. Mean change from baseline in disability score, as measured by the HIT-6, at 4 weeks after the final (third) dose of IMP | — |
Countries
Asia except Japan, Japan
Outcome results
None listed