Study ID: TV48125-MH-40142 | 2019-001989-15

Study Title

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

Teva Identifier

TV48125-MH-40142 | 2019-001989-15

ClinicalTrials.gov Identifier

NCT04041284

Study Status

Active, not recruiting

Trial Condition(s)

Migraine | Major Depressive Disorder

Interventions

Drug: Fremanezumab | Drug: Placebo

EudractCT Number

2019-001989-15

Study Description

The primary objective is to evaluate the efficacy of monthly 225 mg sc fremanezumab in adult patients with migraine and major depressive disorder (MDD)

The secondary objectives are to evaluate the efficacy of monthly 225 mg sc of fremanezumab in adult patients 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 patients with migraine and MDD.

The total duration of patient participation in the study is planned to be approximately 28 weeks.


Key Participation Requirements

Gender

Female, Male

Age Range

18 Years to 70 Years

Trial Duration

September 13, 2019 - February 21, 2022

Phase

Phase 4

Study Type

Interventional


Location - Where to Participate

You may contact 1-888-483-8279 or email USMedInfo@tevapharm.com to obtain more information about study locations.

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