NCT02629861

Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) vs Placebo for the Preventive Treatment of Episodic Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 875 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate two doses of TEV-48125 in adult patients with episodic migraine

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Fremanezumab	Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.
DRUG	Placebo	Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.

Timeline

• Start date: 2016-03-23
• Primary completion: 2017-04-10
• Completion: 2017-04-10
• First posted: 2015-12-14
• Last updated: 2021-11-09
• Results posted: 2018-11-08

Locations

275 sites across 9 countries: United States, Canada, Czechia, Finland, Israel, Japan, Poland, Russia, Spain

Regulatory

• FDA-regulated drug study