Status:
COMPLETED
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Migraine
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly \[except for a loading dose of 675 mg for CM patients\] or at 675 mg every 3 ...
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 or Episodic 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 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.
- 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
- \- 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 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03303105
Start Date
December 7 2017
End Date
June 16 2020
Last Update
February 17 2023
Active Locations (1)
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1
Saitama Medical University Hospital
Iruma, Japan