NCT02638103

Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine

A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,890 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous (SC) administration of TEV-48125 in adult participants with chronic migraine (CM) or episodic migraine (EM). Participants with CM or EM who complete the pivotal efficacy studies of TEV-48125 (TV48125-CNS-30049 \[NCT02621931\] and TV48125-CNS-30050 \[NCT02629861\]) and agree to participate in this study; and new participants meeting eligibility criteria (not rolling over from pivotal studies), will be enrolled in this study.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Fremanezumab	Fremanezumab will be administered as per the dose and schedule specified in the respective arms.
DRUG	Placebo	Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.

Timeline

• Start date: 2016-02-26
• Primary completion: 2018-06-06
• Completion: 2018-12-08
• First posted: 2015-12-22
• Last updated: 2021-11-09
• Results posted: 2019-08-28

Locations

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

Regulatory

• FDA-regulated drug study