Status:
COMPLETED
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Migraine
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously self-administer TEV...
Eligibility Criteria
Inclusion
- Patient has a history of migraine (according to the ICHD-3 criteria) diagnosis for ≥12 months prior to giving informed consent.
- Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4 days in baseline information collected during the 28-day screening period
Exclusion
- History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
- Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following conditions:
- Less than 5 months has passed since the final administration of AMG334, ALD304, or LY2951742.
- Less than 1 year has passed since the final administration of TEV-48125
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2020
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04355117
Start Date
June 17 2020
End Date
November 11 2020
Last Update
October 28 2021
Active Locations (1)
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1
Sendai Zutsu No-Shinkei Clinic
Sendai, Japan