Phase 4
N=353
A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder
Migraine · Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04041284 ↗Enrolled (actual)
353
Serious AEs
1.0%
Results posted
Oct 2023
Primary outcome: Primary: Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week DB Treatment Phase After the First Dose of Study Drug — -2.9; -5.1 days — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fremanezumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week DB Treatment Phase After the First Dose of Study Drug |
-2.9; -5.1 | <0.0001 sig |
| SECONDARY Change From Baseline in Hamilton Depression Rating Scale-17 (HAM-D 17) Items Total Score at Week 8 |
-4.6; -6.0 | 0.0205 sig |
| SECONDARY Number of Participants With ≥50% Reduction in Monthly Average Number of Migraine Days During the 12 Weeks After the First Dose of Study Drug |
24; 57 | <0.0001 sig |
| SECONDARY Change From Baseline in Migraine-Specific Quality of Life (MSQoL) Questionnaire Role Function-Restrictive and Role Function-Preventive Domain Scores at Week 12 |
15.9; 27.2; 12.3; 22.2 | <0.0001 sig |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Scale Score at Weeks 4, 8, and 12 |
-0.4; -0.6; -0.6; -0.1; -0.8; -1.1 | 0.0915 |
| SECONDARY Change From Baseline in 6-Item Headache Impact Test (HIT-6) Disability Score at Week 12 |
-5.2; -8.8 | <0.0001 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
48; 70; 31; 29 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values |
0; 5; 2; 1 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Physical Examination Findings |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Drug Hypersensitivity and Seasonal Allergy |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Number of Participants Who Used Concomitant Medication |
173; 173; 160; 163 | — |
| SECONDARY Number of Participants Who Used Concomitant Medication for Migraine/Headache |
170; 169; 156; 160 | — |
| SECONDARY Number of Participants Who Did Not Complete the Study Due to AE |
0; 3; 0; 0 | — |
| SECONDARY Number of Participants Reporting Any Suicidal Ideation or Suicidal Behavior According to the Columbia Suicide Severity Rating Scale (C-SSRS) |
0; 0; 177; 176; 0; 0 | — |
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.
Eligibility 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 anothe
Data sourced from ClinicalTrials.gov (NCT04041284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.