NCT01285401

Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment

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®

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Relapsing-Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	VigantOL oil plus interferon beta-1a (Rebif)	VigantOL oil 6,670 International Units per day (IU/d) (167 microgram per day \[mcg/day\]), was administered orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) administered orally for 44 weeks on top of Rebif 44mcg three times per week (tiw) administered subcutaneously.
DRUG	Placebo plus interferon beta-1a (Rebif)	Matching placebo daily, orally administered matched placebo for 48 weeks on top of Rebif 44 mcg tiw.
BIOLOGICAL	Interferon beta-1a (Rebif®) alone	Rebif® 44 mcg tiw, sub-cutaneously alone.

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2011-01-28
• Last updated: 2016-11-28
• Results posted: 2016-07-11

Locations

38 sites across 12 countries: Austria, Denmark, Estonia, Finland, Germany, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland