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
- Primary objectives: The primary objective is to evaluate the efficacy of monthly 225 mg sc fremanezumab in adult patients with migraine and major depressive disorder (MDD). Secondary objectives: 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 group
- Adult, Older Adult
- Age Range
- 18 Years to 70 Years
- Trial Duration
- September 19, 2019 - August 31, 2022
- Phase
- Phase 4
