A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · May 23, 2019

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • approved for study participation by the Fibromyalgia Eligibility Review Committee
• • body mass index of 18.5 to 45 kilograms (kg)/square meter (m\^2) and a body weight ≥45 kg
• • agree to use only acetaminophen as rescue medication for FM-related pain (up to 1000 mg per dose and not to exceed 3000 mg/day for any indication throughout the study period)
• • non-pharmacologic interventions (including normal daily exercise routines, chiropractic care, physical therapy, psychotherapy, and massage therapy) are unchanged for a minimum of 30 days prior to screening and will remain unchanged throughout the study
• • agree to maintain a usual and unchanged physical exercise regimen
• * must be of nonchildbearing potential or, defined as:
• • women surgically sterile by documented complete hysterectomy, bilateral oophorectomy, or
• • bitubal ligations or confirmed to be postmenopausal (at least 1 year since last menstrual period) and
• • menopausal women confirmed by a follicle-stimulating hormone \>35 units (U)/liter (L)
• • men surgically sterile by documented vasectomy OR
• If of childbearing potential, patients must meet any of the following criteria:
• • must use highly effective contraception method with their partners during the entire study period and for 5 months after the last dose of the study drug.
• • sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period.
• • female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).
• • must agree not to participate in another interventional study from the screening period through the end of study (EOS) visit o Additional criteria apply, please contact the investigator for more information
• Exclusion Criteria:
• • unable or unwilling to discontinue/washout of prohibited medications
• • ongoing pain that would confound or interfere with the assessment of the participant's FM pain or require excluded therapies during the participant's participation in this study.
• • surgery planned during the study period
• • receiving prophylactic treatment for migraine-related disorders, including topiramate, valproic acid, onabotulinumtoxinA, amitriptyline, and nortriptyline
• • known history of clinically significant or unstable hematologic, cardiac, or thromboembolic events
• • known history of suicide attempt, suicidal behavior, or suicidal ideation within the last 12 months
• • lifetime history of any psychotic and/or bipolar disorder
• • current, untreated, moderate or severe major depressive disorder and/or anxiety
• • known history of hypersensitivity reactions to injected proteins, including monoclonal antibodies (mAbs) and animal venoms, or a history of Stevens-Johnson Syndrome/toxic epidermal necrolysis syndrome o Additional criteria apply, please contact the investigator for more information

Trial Officials