Multiple Sclerosis is a chronic progressive disease that often follows a relapsing-remitting course, with active episodes of exacerbations followed by periods of remission. The primary patho-physiological event is the autoimmune attack on myelin sheaths of nerves that affects the speed of nerve conduction in the brain and spinal cord. Primary symptoms include visual abnormalities, stiffening of extremities and a variety of other physical and eventually psychological issues.
So far, there are only a few viable treatment options that mainly focus on aborting an episode of exacerbation or prolonging the remission in MS patients. However, Multiple Sclerosis researchers are beginning a new study to evaluate the efficacy and therapeutic effectiveness of Gilenya (Fingolimod) in the management of MS against other disease modifying therapies.
The 12-month, open level study, sponsored by Novartis, will evaluate the retention of Multiple Sclerosis patients with Fingolimod against other MS DMT regimens. Approximately 1,000 patients will be enrolled in the PREFER MS Study, with eligibility criteria that stipulates the following:
– The study participants must be in the early stages of the relapsing-remitting form of MS and within the 18-65 year age range.
– Participants must have a history of taking disease modifying MS therapy, with no more than 1 class of drugs, for a maximum of 5 years.
– Participants may also be new MS patients who have not been exposed to any DMT treatments thus far for the management of MS.
Exclusion criteria includes (but is not limited to), bradycardia (resting heart rate below 45 bpm), history of malignancy or other immune disorders, ECG abnormalities, sleep apnea, pregnancy, neurological conditions, and pulmonary abnormalities.
Patients will be randomly assigned to the study group (therapy with Gilenya in a dose of 0.5 mg/day) or one of the DMT (Capaxone or glatiramer acetate and Interferon Beta preparations like Rebif, Exctavia, Avonex, Betaseron). During the study, patients can be switched to other treatment regimens to maximize safety, tolerability, convenience and other efficacy related issues.
Besides assessing the patient adherence to the regimen, scientists at USCF are also interested in learning about different factors that affect the compliance and adherence to a regimen; like history of adverse events, subjective satisfaction, cognitive impairment, etc. It is expected that the results of the study will be available by early 2015.
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