St. Lawrence Health’s Clinical and Rural Health Research Department is looking for individuals who would like to be part of its first Multiple Sclerosis (MS) clinical trial.
Director of Clinical Research Carly Lovelett, CCRP, noted thepurpose of this study is to compare the effects, good or bad, of the investigational oral drug fenebrutinib, versus teriflunomide on patients with Relapsing Multiple Sclerosis.
“MS is a chronic, inflammatory and degenerative disease that affects nearly a million people in the United States. Only through clinical studies like these can we assess and approve new treatments to help reduce MS-related disability and prevent relapses of the disease,” Ms. Lovelett said.
Participants will be randomly assigned to daily treatment with fenebrutinib and a placebo matching teriflunomide, or daily treatment with teriflunomide and a placebo matching fenebrutinib. Because this is a “blinded” study, the placebo will ensure that neither the patient nor the researchers are aware of which active treatment participants are receiving. This type of blinding helps maintain the integrity of the study data and results.
The primary outcome of both studies will compare how treatment affects the annual rate of relapses. Secondary outcomes include disability worsening, disease activity on MRI scans, physical function, cognition, and safety.
To qualify as a study participant, individuals must meet the following requirements:
Clinical trial participants will be asked to be involved for approximately two years, and attend study clinic appointments, including a screening visit and follow-up visit.
“The appointments are necessary so we can monitor their health and see how they are responding to their assigned study drug,” Ms. Lovelett said. “Participants will not have to pay for the study drug or any of the study-related assessments, such as an MRI, blood draws, or clinic visits.
“It is important to note that participation in this study is always voluntary; even after a patient is enrolled in the study they are free to discontinue at any time,” she continued.
March is Multiple Sclerosis Month, and according to the Mayo Clinic, MS is a disabling disease of the brain and spinal cord. Symptoms may differ greatly between those afflicted, and may include tremors, vision problems, slurred speech, fatigue, dizziness, tingling or pain, and bowel or bladder function issues. There is no cure for MS; however, treatments are available that can speed up the recovery from attacks and help manage symptoms.
To learn more about the Clinical Trial through St. Lawrence Health and how to become involved, contact Clinical Research at (315) 261-6311, or Neurologist Hamza Malek, MD, at (315) 261-5944.
The MS studies are being sponsored by F. Hoffmann-La Roche. Learn more about the SLH Clinical Research Department.
