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 or Episodic 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 2 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: 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 |
|---|---|
| safety Number of Participants With Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1. Number of migraine days 2. Number of headache days of at least moderate severity | — |
Countries
Asia except Japan, Japan
Outcome results
None listed