NCT04355117

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

A Multicenter, Open-label Trial to Evaluate the Safety of TEV-48125 When Subcutaneously Self-administered in Migraine Patients at the Trial Site and at Home

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	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.	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.

Timeline

• Start date: 2020-06-17
• Primary completion: 2020-11-11
• Completion: 2020-11-11
• First posted: 2020-04-21
• Last updated: 2021-10-28
• Results posted: 2021-10-28

Locations

1 site across 1 country: Japan