Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Episodic Migraine
- Conditions
- Migraine
- Registration Number
- JPRN-jRCT2080223669
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Subcutaneous administration of fremanezumab for 3 months at 675 mg/3 months or 225 mg/1 month was effective in patients with episodic migraine (EM). Subjects reported an overall improvement in quality of life. No major safety issues were noted with fremanezumab administration, and fremanezumab was well tolerated. Based on the above results, fremanezumab is expected to be a beneficial treatment option for patients with EM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 357
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 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 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
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. 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 efficacy<br>Mean change from baseline in the monthly (28 days) average number of migraine days during the 12-week period after the first dose of Investigational Medicinal Product (IMP)
- Secondary Outcome Measures
Name Time Method efficacy<br>1. Proportion of subjects reaching at least 50% reduction in the monthly average number of migraine days during the 12-week period after the first dose of IMP<br>2. 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<br>3. Mean change from baseline in the monthly average number of migraine days during the 12-week period after the first dose of IMP in patients not receiving concomitant preventive migraine medications<br>4. Mean change from baseline in disability score, as measured by the MIDAS questionnaire, at 4 weeks after the final (third) dose of IMP