Status:
COMPLETED
Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Migraine
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 \[monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months\] compar...
Eligibility Criteria
Inclusion
- 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
- Patient fulfills the criteria for Chronic migraine in baseline information collected during the 28 day screening period
- 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.
- 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
- 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
- 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.
- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
571 Patients enrolled
Trial Details
Trial ID
NCT03303079
Start Date
December 19 2017
End Date
November 30 2019
Last Update
June 15 2021
Active Locations (1)
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1
Saitama Medical University Hospital
Iruma, Japan