A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder
Public ClinicalTrials.gov record NCT04041284. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Followed by an Open-Label Extension to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04041284
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 353 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 13, 2019 (Actual)
- Primary completion
- Aug 31, 2022 (Actual)
- Completion
- Aug 31, 2022 (Actual)
- Last update posted
- Oct 2, 2023
2019 – 2022
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Teva Investigational Site 14330 | Little Rock | Arkansas | 72205 | — |
| Teva Investigational Site 14337 | San Diego | California | 92103 | — |
| Teva Investigational Site 14342 | Denver | Colorado | 80218 | — |
| Teva Investigational Site 14332 | Stamford | Connecticut | 06905 | — |
| Teva Investigational Site 14329 | Hialeah | Florida | 33012 | — |
| Teva Investigational Site 14334 | Jacksonville | Florida | 32256 | — |
| Teva Investigational Site 14341 | Orlando | Florida | 32801 | — |
| Teva Investigational Site 14411 | Tampa | Florida | 33634 | — |
| Teva Investigational Site 14336 | Pikesville | Maryland | 21208 | — |
| Teva Investigational Site 14331 | Waltham | Massachusetts | 02451 | — |
| Teva Investigational Site 14343 | Bolivar | Missouri | 65613 | — |
| Teva Investigational Site 14335 | Brooklyn | New York | 11229 | — |
| Teva Investigational Site 14345 | The Bronx | New York | 10461 | — |
| Teva Investigational Site 14340 | Portland | Oregon | 97214 | — |
| Teva Investigational Site 14338 | Philadelphia | Pennsylvania | 19107 | — |
| Teva Investigational Site 14333 | Memphis | Tennessee | 38119 | — |
| Teva Investigational Site 14339 | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04041284, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04041284 live on ClinicalTrials.gov.