ong-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
- Conditions
- Migraine
- Registration Number
- JPRN-jRCT2080223670
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Subcutaneous administration of fremanezumab at 675 mg/3 months or 225 mg/1 month in patients with chronic migraine or episodic migraine reduced the number of migraine days and the number of headache days of at least moderate severity from 1 month after initial administration, and this effect was maintained throughout the treatment period. No major safety issues were noted with long-term administration, and fremanezumab was confirmed to be well tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 50
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
Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Number of Participants With Adverse Events
- Secondary Outcome Measures
Name Time Method efficacy<br>1. Number of migraine days<br>2. Number of headache days of at least moderate severity