A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients

• Status: Completed
• Trial end date: 2020-11-11
• Target enrollment: 0
• Participant gender: All

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 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses. The first dose will be self-administered at the trial site under the supervision of the investigator and the second dose will be self-administered at home.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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