drugset / Trial / NCT04355117

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

NCT04355117

Phase 3 Completed 71 enrolled Otsuka Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-06-17
Primary completion
2020-11-11
Completion
2020-11-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Fremanezumab Monoclonal antibody 225 mg Subcutaneous

Indications