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

NCT01285401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2016-11-28

Study results available
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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

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Manolo Beelke, MD, PhD · WCT Worldwide Clinical Trials GER GmbH Germany

  • Prof. Dr. Raymond Hupperts, MD · Dept of Neurology, Orbis Medical Center Sittard, Maastricht University, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2015-04-30
Completion
2015-05-31

Countries

  • Austria
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Portugal
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01285401 on ClinicalTrials.gov