A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT04041284|
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : October 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine Major Depressive Disorder||Drug: Fremanezumab Drug: Placebo||Phase 4|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||September 13, 2019|
|Estimated Primary Completion Date :||February 21, 2022|
|Estimated Study Completion Date :||February 21, 2022|
monthly 225 mg. In the open-label extension phase starting at week 12, all patients will receive active treatment with a quarterly dose of 675 mg sc
Monthly 225 mg subcutaneous
Other Name: TEV-48125, LBR-101, PF-04427429, RN307
|Placebo Comparator: Placebo||
- Mean change in the monthly average number of migraine days [ Time Frame: Baseline - Week 12 ]
- Mean change in depression symptoms [ Time Frame: Day 1-Week 8 ]Mean change measured by Hamilton Depression Rating Scale-17 items (HAM-D 17) Higher scores indicate greater depression severity; lower scores indicate minimal/no presence of depression
- Number of participants with 50% or more reduction of migraine days [ Time Frame: Baseline - Week 12 ]
- Mean change in quality of life [ Time Frame: Randomization (day 1) - week 12 ]Measured by Migraine-Specific Quality of Life (MSQoL) questionnaire. The 14-item instrument measures how migraines affect daily functioning across three domains: Role function Restrictions, Role function prevention, and Emotional Function. Scores range from 0 to 100. Higher scores indicate better quality of life.
- Mean change in disability score for overall impact as measured by Clinical Global Impression-Severity (CGI-S) [ Time Frame: Day 1, Week 4, 8, 12 ]
- Mean change in disability score for overall impact as measured by Headache Impact Test (HIT-6) [ Time Frame: Day 1, Week 12 ]
- Number of participants reporting adverse events [ Time Frame: Up to Week 24 ]Adverse events include clinically significant vital signs, physical exam findings, hypersensitivity, and allergic reactions
- Number of participants who use concomitant medication for adverse events [ Time Frame: Up to Week 24 ]
- Percentage of participants who do not complete the study due to adverse events [ Time Frame: Up to Week 24 ]
- Change in eC-SSRS (electronic Columbia-Suicide Severity Rating Scale) scores [ Time Frame: Baseline, Week 24 ]
Suicidal ideation is assessed at 5 distinct levels of increasing severity:
Level 1: Wish to be Dead Level 2: Non-Specific Active Suicidal Thoughts Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan Level 5: Active Suicidal Ideation with Specific Plan and Intent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041284
|Contact: Teva U.S. Medical Information||1-888-483-8279||USMedInfo@tevapharm.com|
|Study Director:||Teva Medical Expert, MD||Teva Pharmaceuticals USA|