Efficacy and Safety of Fremanezumab for Migraine in Patients With Major Depressive Disorder

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
Completed
Trial Condition(s)
Migraine | Major Depressive Disorder
Interventions
Drug: Fremanezumab | Drug: Placebo
EudraCT 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.

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EudraCT Link


Key Participation Requirements

Gender
Female, Male
Age Range
18 Years to 70 Years
Trial Duration
September 19, 2019 - August 31, 2022
Phase
Phase 4

Additional info

Study Type

Interventional