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A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04041284
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )

Brief Summary:

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 ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: fremanezumab
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
Drug: Fremanezumab
Monthly 225 mg subcutaneous
Other Name: TEV-48125, LBR-101, PF-04427429, RN307

Placebo Comparator: Placebo Drug: Placebo
Matching Placebo




Primary Outcome Measures :
  1. Mean change in the monthly average number of migraine days [ Time Frame: Baseline - Week 12 ]

Secondary Outcome Measures :
  1. 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

  2. Number of participants with 50% or more reduction of migraine days [ Time Frame: Baseline - Week 12 ]
  3. 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.

  4. 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 ]
  5. Mean change in disability score for overall impact as measured by Headache Impact Test (HIT-6) [ Time Frame: Day 1, Week 12 ]
  6. 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

  7. Number of participants who use concomitant medication for adverse events [ Time Frame: Up to Week 24 ]
  8. Percentage of participants who do not complete the study due to adverse events [ Time Frame: Up to Week 24 ]
  9. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant has a diagnosis of migraine with onset at ≤50 years of age.
  • Prior to the screening visit 1 the participant has a 12-month history of either migraine or headache consistent with migraine
  • The participant agrees not to initiate any migraine preventive during the study. Up to 30% of participants, however, may take a single such medication previously prescribed for the treatment of migraine.
  • The participant has a history of major depressive disorder (MDD) at least 12 months prior to the screening visit. Participants may take a single medication prescribed for the treatment of depression as long as the dose of that medication has been stable for at least 8 weeks prior to the screening visit and expects to remain at the stable dose throughout the study.
  • The participant has a body weight ≥ 45 kg and a body mass index within the range of 17.5 to 34.9 kg/m2, inclusive.
  • Women of child-bearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study and for 6 months after discontinuation of IMP.
  • Men must be sterile or, if they are potentially fertile/reproductively competent (not congenitally sterile) and their female partners are of child-bearing potential, must use a condom for the duration of the study and for 6 months after discontinuation of IMP.

NOTE: Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The participant has failed 4 or more different medication classes to treat depression in their lifetime.
  • The participant has used an intervention/device (eg, scheduled nerve blocks, implantable vagal nerve stimulation, and transcranial magnetic stimulation) for migraine or depression during the 2 months prior to screening.
  • The participant has used electroconvulsive therapy at any time.
  • The participant suffers from constant or nearly constant headache, defined as having headaches for more than 80% of the time he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if participant has headaches 80% or less of the time he/she is awake on most days.
  • The participant has a clinical history of a severe or uncontrolled psychiatric disorder, to include the following, or at the discretion of the investigator for any clinically significant psychiatric history that would likely interfere with full participation in the study:

    • Lifetime exclusion: suicide attempt
    • In the past 6 months exclusion: suicidal ideation, or other psychoactive spectrum disorders including schizoaffective disorder, delusional disorder, depression with psychotic features, and catatonic disorder.
  • The participant has a known infection or history of human immunodeficiency virus, tuberculosis, any history of Lyme disease, or chronic hepatitis B or C infection.
  • The participant has a past or current history of cancer, except for appropriately treated non-melanoma skin carcinoma.
  • The participant is a pregnant or nursing female or plans to become pregnant during the study, including the 6-month period after the administration of the last dose.
  • The participant has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome.
  • Participant has received onabotulinumtoxinA for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the 3 months before screening visit.
  • The participant has a history of hypersensitivity reactions to injected proteins, including monoclonal antibodies.
  • The participant has participated in a clinical study of a new chemical entity or a prescription medicine within 2 months of the screening visit or 3 months in case of biologics if the half-life of the biologics is unknown or 5 half-lives, whichever is longer, or is currently participating in another study of an IMP (or a medical device).
  • The participant has failed treatment (based on tolerability and/or a lack of efficacy) with any monoclonal antibodies targeting the CGRP pathway (erenumab, eptinezumab, galcanezumab, or fremanezumab) or have taken the medications within 5 half-lives of the screening visit (V1) or take them during the study.
  • The participant has any clinically significant uncontrolled medical condition (treated or untreated).
  • The participant has a history of alcohol or drug abuse in the opinion of the investigator.
  • The participant has evidence or medical history of psychotic symptoms as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria such as delusions, hallucinations, or disorganized speech in the past 1 month.

NOTE: Additional criteria apply, please contact the investigator for more information


Information from the National Library of Medicine

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


Contacts
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Contact: Teva U.S. Medical Information 1-888-483-8279 USMedInfo@tevapharm.com

Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT04041284    
Other Study ID Numbers: TV48125-MH-40142
2019-001989-15 ( EudraCT Number )
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases