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

  • STATUS
    Recruiting
  • End date
    Feb 21, 2022
  • participants needed
    340
  • sponsor
    Teva Branded Pharmaceutical Products R&D, Inc.
Updated on 23 November 2020
Investigator
Teva U.S. Medical Information
Primary Contact
Teva Investigational Site 14336 (4.3 mi away) Contact
+60 other location
body mass index
depression
headache
major depressive disorder
fremanezumab

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.

Details
Treatment Placebo, Fremanezumab
Clinical Study IdentifierNCT04041284
SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last Modified on23 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Migraine and Cluster Headaches or Migraine (Pediatric) or Endogenous depression or Migraine (Adult) or Primary Stabbing Headache or Major depression o...?
Do you have any of these conditions: Primary Stabbing Headache or Migraine and Cluster Headaches or Migraine or Migraine (Pediatric) or migraines or Migraine (Adult) or major depressive d...?
Do you have any of these conditions: Migraine (Adult) or Migraine (Pediatric) or Endogenous depression or Major depression or Migraine or Primary Stabbing Headache or major depressive dis...?
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
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