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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01285401
First received: January 26, 2011
Last updated: May 31, 2016
Last verified: May 2016
Results First Received: May 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Relapsing-Remitting Multiple Sclerosis
Interventions: Drug: VigantOL oil plus interferon beta-1a (Rebif)
Drug: Placebo plus interferon beta-1a (Rebif)
Biological: Interferon beta-1a (Rebif®) alone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Total 232 subject were randomized in the study was analyzed based on 229 subjects since 3 subjects of the 232 randomized subjects were excluded from analysis as they did not received any medication.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
VigantOL Oil Interferon Beta-1a (Rebif) Subjects with 25-hydroxyvitamin D [25(OH)D3] serum levels below 150 nano mol per liter (nmol/L) received Vigantol oil 6,670 international unit per day (IU/d) [167 microgram per day (mcg/d)] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous three times a week (tiw).
Placebo Interferon Beta-1a (Rebif) Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.

Participant Flow:   Overall Study
    VigantOL Oil Interferon Beta-1a (Rebif)     Placebo Interferon Beta-1a (Rebif)  
STARTED     115     117  
Treated     113     116  
COMPLETED     98     88  
NOT COMPLETED     17     29  
Prematurely withdrawn from the study                 17                 29  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis set included all randomized subjects who received at least 1 dose of the investigational medicinal product (IMP).

Reporting Groups
  Description
VigantOL Oil Interferon Beta-1a (Rebif) Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
Placebo Interferon Beta-1a (Rebif) Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
Total Total of all reporting groups

Baseline Measures
    VigantOL Oil Interferon Beta-1a (Rebif)     Placebo Interferon Beta-1a (Rebif)     Total  
Number of Participants  
[units: participants]
  115     117     232  
Age  
[units: years]
Mean (Standard Deviation)
  34.2  (8.1)     33.6  (9.3)     33.9  (8.8)  
Gender  
[units: subjects]
     
Female     78     79     157  
Male     37     38     75  



  Outcome Measures
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1.  Primary:   Percentage of Subjects With Disease Activity Free Status up to Week 48   [ Time Frame: Up to Week 48 ]

2.  Secondary:   Percentage of Relapse-free Subjects at Week 48   [ Time Frame: Week 48 ]

3.  Secondary:   Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48   [ Time Frame: Week 48 ]

4.  Secondary:   Number od Subjects With Confirmed EDSS Progression   [ Time Frame: Baseline upto 48 Weeks ]

5.  Secondary:   Cumulative Number of Relaxation Time 1 (T1) Gadolinium Enhancing Lesions at Week 48   [ Time Frame: 48 Weeks ]

6.  Secondary:   Mean Number of Combined Unique Active (CUA) Lesions Per Subject Per Scan at Week 48   [ Time Frame: 48 Weeks ]

7.  Secondary:   Cumulative Number of New Combined Unique Active (CUA) Lesions at Week 48   [ Time Frame: 48 Weeks ]

8.  Secondary:   Mean Change From Baseline in the Total Volume of T2 Lesions at Week 48 (T2 Burden of Disease)   [ Time Frame: Baseline, 48 Weeks ]

9.  Secondary:   Percentage of Subjects Free From T1 Gadolinium Enhancing Lesions at Week 48   [ Time Frame: 48 Weeks ]

10.  Secondary:   Percentage of Subjects Free From New T1 Hypointense Lesions (Black Holes) at Week 48   [ Time Frame: 48 Weeks ]

11.  Secondary:   Percentage of New T1 Hypointense Lesions (Black Holes) at Week 48 Within the Subgroup of New or Enlarging Non-enhancing T2 Lesions   [ Time Frame: 48 Weeks ]

12.  Secondary:   Number of Subjects With Relapse   [ Time Frame: Baseline upto 48 weeks ]

13.  Secondary:   Annualized Relapse Rate at Week 48   [ Time Frame: 48 weeks ]

14.  Secondary:   Total Number of Reported Relapses at All Time Points up to 48 Weeks   [ Time Frame: 48 weeks ]

15.  Secondary:   Percentage of Subjects Treated With Glucocorticoids Due to Relapses   [ Time Frame: Baseline upto 48 weeks ]

16.  Secondary:   Mean Change From Baseline in the Total Volume of T1 Hypo Intense Lesions at Week 48   [ Time Frame: Baseline, 48 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com



Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01285401     History of Changes
Other Study ID Numbers: EMR 200136-532
2010-020328-23 ( EudraCT Number )
Study First Received: January 26, 2011
Results First Received: May 31, 2016
Last Updated: May 31, 2016
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Switzerland: Swissmedic