Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine
- Conditions
- Migraine
- Registration Number
- JPRN-jRCT2080223667
- 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 (following a loading dose of 675 mg) was effective in patients with chronic migraine (CM). Subjects reported an overall improvement in quality of life. No major safety issues were noted with fremanezumab treatment, and fremanezumab was well tolerated. Based on the above results, fremanezumab is expected to be a beneficial treatment option for patients with CM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 571
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
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
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 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 Outcome Measures
Name Time Method efficacy<br>1. Mean change from baseline in the monthly average number of migraine days during the 12-week period after the first dose of IMP<br>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<br>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<br>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<br>5. Mean change from baseline in disability score, as measured by the HIT-6, at 4 weeks after the final (third) dose of IMP