NCT04041284

A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the efficacy of monthly 225 mg sc fremanezumab in adult participants with migraine and major depressive disorder (MDD) The secondary objectives are to evaluate the efficacy of monthly 225 mg sc of fremanezumab in adult participants with migraine and MDD on the reduction of MDD symptoms, responder rates in monthly migraine days, improving quality of life, improving disability, and the safety and tolerability of monthly 225 mg sc and quarterly 675 mg sc fremanezumab in adult participants with migraine and MDD. The total duration of participant participation in the study is planned to be approximately 28 weeks.

Conditions

• Migraine
• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Fremanezumab	Monthly 225 mg subcutaneous
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2019-09-13
• Primary completion: 2022-08-31
• Completion: 2022-08-31
• First posted: 2019-08-01
• Last updated: 2023-10-02
• Results posted: 2023-10-02

Locations

64 sites across 13 countries: United States, Czechia, Finland, France, Germany, Greece, Israel, Italy, Poland, Russia, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study