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NCT04041284 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder
A Phase 4 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 353
- Enrollment target
NCT04041284 is a Phase 4 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 353 participants.
The verdict
NCT04041284, a Phase 4 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 353 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Fremanezumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2019-09-13 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04041284
The ClinicalTrials.gov registry entry for NCT04041284 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04041284 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04041284 about?
NCT04041284 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder". 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 r...
What is the current status of trial NCT04041284?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 353 participants. The study started on 2019-09-13. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT04041284?
The interventions under investigation include: Placebo (DRUG), Fremanezumab (DRUG).
Who is sponsoring clinical trial NCT04041284?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
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