NCT03303079

Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial Evaluating the Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 571 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 \[monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months\] compared with placebo for preventive treatment in Chronic Migraine patients

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	TEV-48125	TEV-48125 will be subcutaneously administered once monthly for 3 months.
DRUG	TEV-48125 or placebo	TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.
DRUG	Placebo	Placebo will be subcutaneously administered once monthly for 3 months.

Timeline

• Start date: 2017-12-19
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2017-10-05
• Last updated: 2021-06-15
• Results posted: 2021-06-15

Locations

1 site across 1 country: Japan