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
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 19, 2019 - August 31, 2022
Phase
- Phase 4
Additional info
Study Type
Interventional
