Relapsing-Remitting Multiple Sclerosis Clinical Trial
Official title:
A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif®
The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone
supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated
with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of
patients with Multiple Sclerosis have Vitamin D deficiency.
Rebif® is known to be an effective treatment for slowing down the progression of MS. The
purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any
benefit on the progression of MS compared to Rebif® and placebo.
Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging
(MRI). The planned study treatment duration for each study participant is 48 weeks, and the
study consists of a total of 8 visits. Study participants who are already passed Week 48 at
the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a
total of 12 visits.
During the study, the participant will undergo physical examination, neurological
assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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