Relapsing-Remitting Multiple SclerosisPhase 2SOLARNCT01285401
Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment
A Phase 2 study testing VigantOL oil plus interferon beta-1a (Rebif) and Interferon beta-1a (Rebif®) alone in people with Relapsing-Remitting Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 38 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- VigantOL oil plus interferon beta-1a (Rebif) and Interferon beta-1a (Rebif®) alone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 38 sitesin 12 countries
- Study dates
- Feb 2011to May 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of a relapsing-remitting form of MS
- Brain and/or spinal MRI with findings typical of MS
- A first clinical event prior to Screening.
- Disease activity
- Expanded Disability Status Scale (EDSS) score of less than, or equal to 4.0 at Screening.
- Currently treated with interferon-beta-1a 44mg (tiw) sc
- Willingness and ability to comply with the protocol
- Written informed consent
Who cannot join
- Pregnancy and lactation period
- Any disease other than MS that could better explain signs and symptoms.
- Complete transverse myelitis or bilateral optic neuritis.
- Currently receiving or use at any time of monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e.g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.
- Use of any cytokine other than interferon or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure
- Use of oral or systemic corticosteroids or ACTH
Show all 28Show fewer
- Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, i.e. primary hyperparathyroidism or granulomatous disorders.
- Have an urine calcium/creatinine (mmol/mmol) ratio greater than 1.0 or hypercalcaemia
- Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.
- Are taking more than 1000 IU (25 µg) of Vitamin D supplement daily.
- Have conditions with increased susceptibility to hypercalcaemia, e.g., known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.
- Have inadequate liver function
- Moderate to severe renal impairment
- Inadequate bone marrow reserve
- History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4).
- History or presence of severe depression, history of suicide attempt, or current suicidal ideation.
- Epilepsy or seizures not adequately controlled by treatment.
- Current or past alcohol or drug abuse.
- Any major medical or psychiatric illness (such as psychosis, bipolar disorder) that in the opinion of the Investigator could create undue risk to the subject or could affect adherence with the trial protocol.
- Known contra-indication to treatment with vitamin D
- Known hypersensitivity to interferon or its excipient(s)
- Known hypersensitivity to gadolinium.
- Any other condition that would prevent the subject from undergoing an MRI scan.
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
- Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening).
- Legal incapacity or limited legal capacity.
- Another current autoimmune disease, except diabetes.
- Have experienced a relapse within 30 days.
Trial locations and contacts
38 sites in 12 countries.
38 sites in 12 countries
Germany10 sites
Research Site
Bad Neustadt / Saale
Research Site
Bamberg
Research Site
Berlin
Research Site
Cologne
Research Site
Erlangen
Research Site
Freiburg im Breisgau
Research Site
Hanover
Research Site
Münster
Research Site
Regensburg
Research Site
Rostock
Denmark5 sites
Research Site
Esbjerg
Research Site
Glostrup Municipality
Research Site
Sønderborg
Research Site
Vejle
Research Site
Viborg
Netherlands5 sites
Research Site
Amsterdam
Research Site
Gouda
Research Site
Nieuwegein
Research Site
Rotterdam
Research Site
Sittard
Switzerland5 sites
Research Site
Bern
Research Site
Lausanne
Research Site
Lugano
Research Site
Sankt Gallen
Research Site
Zurich
About this study
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.
Read more
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
- Being tested
- VigantOL oil plus interferon beta-1a (Rebif), Placebo plus interferon beta-1a (Rebif), Interferon beta-1a (Rebif®) alone
- Keywords
- Multiple Sclerosis, Rebif, VigantOL® oil, Vitamin D, Add-on treatment
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VigantOL oil plus interferon beta-1a (Rebif)Drug
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.
Placebo plus interferon beta-1a (Rebif)Drug
Matching placebo daily, orally administered matched placebo for 48 weeks on top of Rebif 44 mcg tiw.
Interferon beta-1a (Rebif®) aloneBiological
Rebif® 44 mcg tiw, sub-cutaneously alone.
| Study group | Role | What they receive |
|---|---|---|
| VigantOL® oil | Experimental | VigantOL oil plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L Receives: Drug: VigantOL oil plus interferon beta-1a (Rebif) |
| Placebo | Placebo comparator | Placebo daily plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L Receives: Drug: Placebo plus interferon beta-1a (Rebif) |
| Rebif | Experimental | Rebif alone in subjects with 25-hydroxy-vitamin D plasma levels equal or higher than 150 nmol/L Receives: Biological: Interferon beta-1a (Rebif®) alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Disease Activity Free Status up to Week 48
Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.
Measured: Up to Week 48
Secondary outcomes (15)
Percentage of Relapse-free Subjects at Week 48
A relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.
Measured: Week 48
Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48
EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.
Measured: Week 48
Number od Subjects With Confirmed EDSS Progression
EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated. A confirmed EDSS progression was defined EDSS greater than or equal to 1.0 point confirmed during a visit performed 6 months later. An EDSS progression was defined as an increase of the EDSS score of at least 1.0 point compared to baseline (SD1) for subjects with a baseline EDSS ≤ 4.0. For subjects with an EDSS score of 0 at baseline (SD1), EDSS progression was defined as an increase of at least 1.5 points. A confirmed EDSS progression was defined as an EDSS progression confirmed after 24 weeks.
Measured: Baseline upto 48 Weeks
Cumulative Number of Relaxation Time 1 (T1) Gadolinium Enhancing Lesions at Week 48
Measured: 48 Weeks
Mean Number of Combined Unique Active (CUA) Lesions Per Subject Per Scan at Week 48
CUA lesions was defined as new T1 (Gd enhancing) lesions, new Relaxation time 2 (T2) lesions, or enlarging T2 lesions.
Measured: 48 Weeks
Cumulative Number of New Combined Unique Active (CUA) Lesions at Week 48
CUA lesions was defined as new T1 (Gd enhancing) lesions, new T2 lesions, or enlarging T2 lesions.
Measured: 48 Weeks
Mean Change From Baseline in the Total Volume of T2 Lesions at Week 48 (T2 Burden of Disease)
Measured: Baseline, 48 Weeks
Percentage of Subjects Free From T1 Gadolinium Enhancing Lesions at Week 48
Measured: 48 Weeks
Percentage of Subjects Free From New T1 Hypointense Lesions (Black Holes) at Week 48
Measured: 48 Weeks
Percentage of New T1 Hypointense Lesions (Black Holes) at Week 48 Within the Subgroup of New or Enlarging Non-enhancing T2 Lesions
Measured: 48 Weeks
Number of Subjects With Relapse
Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.
Measured: Baseline upto 48 weeks
Annualized Relapse Rate at Week 48
Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.
Measured: 48 weeks
Total Number of Reported Relapses at All Time Points up to 48 Weeks
Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.
Measured: 48 weeks
Percentage of Subjects Treated With Glucocorticoids Due to Relapses
Relapse was defined as neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both as neurological abnormality separated by at least 30 days from onset of a preceding MS attack and Neurological abnormality lasting for at least 24 hours, absence of fever or known infection greater than 37.5 degree centigrade /99.5 degree fahrenheit , objective neurological impairment, correlating with the subject's reported symptoms, defined as either increase in at least one of the functional systems of the EDSS or increase of the total EDSS score and occurrence of paraesthesia, fatigue, mental symptoms, and/or vegetative symptoms without any additional symptom will not be classified as an MS attack.
Measured: Baseline upto 48 weeks
Mean Change From Baseline in the Total Volume of T1 Hypo Intense Lesions at Week 48
Measured: Baseline, 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manolo Beelke, MD, PhD, Study director, WCT Worldwide Clinical Trials GER GmbH GermanyProf. Dr. Raymond Hupperts, MD, Principal investigator, Dept of Neurology, Orbis Medical Center Sittard, Maastricht University, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285401
- Sponsor's protocol ID
- EMR 200136-532
- Other IDs
- 2010-020328-23
- Acronym
- SOLAR
- Status last verified
- Oct 2016
- First submitted
- 26 Jan 2011
- Last updated
- 28 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hupperts R, Smolders J, Vieth R, Holmoy T, Marhardt K, Schluep M, Killestein J, Barkhof F, Beelke M, Grimaldi LME; SOLAR Study Group. Randomized trial of daily high-dose vitamin D3 in patients with RRMS receiving subcutaneous interferon beta-1a. Neurology. 2019 Nov 12;93(20):e1906-e1916. doi: 10.1212/WNL.0000000000008445. Epub 2019 Oct 8.
PubMed 31594857
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®
- ClinicalTrials.gov ID
- NCT01285401
- Acronym / sponsor ID
- SOLAR / EMR 200136-532
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Rebif, VigantOL® oil, Vitamin D, Add-on treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Posted 11 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VigantOL® oil | Experimental | Drug: VigantOL oil plus interferon beta-1a (Rebif)VigantOL oil plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L |
| Placebo | Placebo comparator | Drug: Placebo plus interferon beta-1a (Rebif)Placebo daily plus Rebif in subjects with 25-hydroxy-vitamin D plasma levels below 150 nmol/L |
| Rebif | Experimental | Biological: Interferon beta-1a (Rebif®) aloneRebif alone in subjects with 25-hydroxy-vitamin D plasma levels equal or higher than 150 nmol/L |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diagnosis of a relapsing-remitting form of MS
- Brain and/or spinal MRI with findings typical of MS
- A first clinical event prior to Screening.
- Disease activity
- Expanded Disability Status Scale (EDSS) score of less than, or equal to 4.0 at Screening.
Key exclusion criteria (28 listed)
- Pregnancy and lactation period
- Any disease other than MS that could better explain signs and symptoms.
- Complete transverse myelitis or bilateral optic neuritis.
- Currently receiving or use at any time of monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e.g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.
- Use of any cytokine other than interferon or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | VigantOL® oil |
| Placebo plus interferon beta-1a (Rebif)Matching placebo daily, orally administered matched placebo for 48 weeks on top of Rebif 44 mcg tiw. | Drug | Placebo |
| Interferon beta-1a (Rebif®) aloneRebif® 44 mcg tiw, sub-cutaneously alone. | Biological | Rebif |
Primary outcome
Percentage of Subjects With Disease Activity Free Status up to Week 48
Time frame: Up to Week 48
Disease activity free status was defined as absence of any of the clinical and imaging parameters related to the assessment of disease activity; no relapses, no expanded disability status scale (EDSS) progression and no new gadolinium (Gd)-enhancing or relaxation time 2 (T2) magnetic resonance imaging (MRI) lesions.
15 secondary outcomes
Percentage of Relapse-free Subjects at Week 48
Time frame: Week 48
Percentage of Subjects Free From Any Expanded Disability Status Scale (EDSS) Progression at Week 48
Time frame: Week 48
Number od Subjects With Confirmed EDSS Progression
Time frame: Baseline upto 48 Weeks
Cumulative Number of Relaxation Time 1 (T1) Gadolinium Enhancing Lesions at Week 48
Time frame: 48 Weeks
Mean Number of Combined Unique Active (CUA) Lesions Per Subject Per Scan at Week 48
Time frame: 48 Weeks
Cumulative Number of New Combined Unique Active (CUA) Lesions at Week 48
Time frame: 48 Weeks
Mean Change From Baseline in the Total Volume of T2 Lesions at Week 48 (T2 Burden of Disease)
Time frame: Baseline, 48 Weeks
Percentage of Subjects Free From T1 Gadolinium Enhancing Lesions at Week 48
Time frame: 48 Weeks
Percentage of Subjects Free From New T1 Hypointense Lesions (Black Holes) at Week 48
Time frame: 48 Weeks
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
Number of Subjects With Relapse
Time frame: Baseline upto 48 weeks
Annualized Relapse Rate at Week 48
Time frame: 48 weeks
Total Number of Reported Relapses at All Time Points up to 48 Weeks
Time frame: 48 weeks
Percentage of Subjects Treated With Glucocorticoids Due to Relapses
Time frame: Baseline upto 48 weeks
Mean Change From Baseline in the Total Volume of T1 Hypo Intense Lesions at Week 48
Time frame: Baseline, 48 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31594857Hupperts R, Smolders J, Vieth R, Holmoy T, Marhardt K, Schluep M, Killestein J, Barkhof F, Beelke M, Grimaldi LME; SOLAR Study Group. Randomized trial of daily high-dose vitamin D3 in patients with RRMS receiving subcutaneous interferon beta-1a. Neurology. 2019 Nov 12;93(20):e1906-e1916. doi: 10.1212/WNL.0000000000008445. Epub 2019 Oct 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manolo Beelke, MD, PhD study director
WCT Worldwide Clinical Trials GER GmbH Germany
Prof. Dr. Raymond Hupperts, MD principal investigator
Dept of Neurology, Orbis Medical Center Sittard, Maastricht University, The Netherlands
38 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VigantOL oil plus interferon beta-1a (Rebif) and Interferon beta-1a (Rebif®) alone in people with Relapsing-Remitting Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 38 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Germany, Denmark, Netherlands, Switzerland, Norway and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Disease Activity Free Status up to Week 48 (time frame: Up to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01285401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.