Clinical Trial 45952

Torrance, CA 90502


Summary:

The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously in reducing pain in adult patients with FM. A secondary objective is to evaluate the effect of fremanezumab on other efficacy measures, including pain, quality of life, sleep, fatigue, improvement in health, physical functioning, and mood. Another secondary objective is to evaluate the safety and tolerability of fremanezumab administered subcutaneously in adult patients with FM.

The total duration of patient participation in the study is planned to be 21 weeks, consisting of a screening period of up to 5 weeks (ranging from 17 to 35 days), and a double-blind treatment period of 16 weeks.



Criteria:
  • Be approved for study participation by the Fibromyalgia Eligibility Review Committee
  • Have a body mass index of 18.5 to 45 kg/m2 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 U/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 (Appendix G) with their partners during the entire study period and for 5 months after the last dose of the IMP.
  • sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period.
  • female patients 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 EOS Visit o Additional criteria apply, please contact the investigator for more information


Qualified Participants May Receive:

Compensation for participating up to $525.00 over the study length.


Available At:

Collaborative Neuroscience Research, LLC Recruiting

Torrance, CA 90502
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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.