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    Summary
    EudraCT Number:2010-020328-23
    Sponsor's Protocol Code Number:EMR200136-532
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLatvia - SAM
    A.2EudraCT number2010-020328-23
    A.3Full title of the trial
    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 44 μg tiw of Rebif®

    SOLAR

    Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients
    with Relapsing-Remitting MS receiving Rebif® treatment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Supplementation of VigantOL® Oil versus Placebo as Add-on in Patients
    with Relapsing-Remitting MS receiving Rebif® treatment.
    A.3.2Name or abbreviated title of the trial where available
    SOLAR
    A.4.1Sponsor's protocol code numberEMR200136-532
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01285401
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Serono
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Serono
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Serono
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurterstr. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151725200
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merckgroup.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vigantol Oel
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono GmbH, Germany
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVigantol Oil
    D.3.2Product code 200106 or EMD 28162
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLECALCIFEROL
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor code200109, EMD 28162, 300910
    D.3.9.3Other descriptive nameCholecalciferol, Vitamin D3
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing-Remitting Multiple Sclerosis
    Russian
    E.1.1.1Medical condition in easily understood language
    Relapsing-Remitting Multiple Sclerosis
    Russian
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Vigantol® oil versus placebo as add-on therapy
    in subjects with Relapsing-Remitting Multiple Sclerosis receiving
    treatment with Rebif®.
    E.2.2Secondary objectives of the trial
    • To assess changes on clinical parameters.
    • To assess changes in MRI parameters.
    • To investigate the safety profile up to the end of the Treatment Period (Week48),
    • To explore pharmacogenetics (PGx), gene expression and circulating biomarkers and to evaluate whether there is a possible relationship to Vigantol® oil treatment outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •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
    •EDSS score of less than, or equal to 4.0 at Screening.
    •Currently treated with interferon-beta-1a 44μg (tiw) sc
    •Willingness and ability to comply with the protocol
    •Written informed consent
    E.4Principal exclusion criteria
    •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
    •Have experienced a relapse within 30 days before the SD1 visit
    •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.
    E.5 End points
    E.5.1Primary end point(s)
    • The proportion of subjects with DAF status at Week 48.
    DAF status is defined as a condition described by the absence of all of the following conditions:
    — Occurrence of relapse
    — EDSS progression
    — New MRI lesions:
    • Gd-enhancing
    • T2 lesions
    E.5.1.1Timepoint(s) of evaluation of this end point
    Proportion of Disease Activity Free subjects at week 48
    E.5.2Secondary end point(s)
    •Proportion of relapse-free subjects at week 48
    •Proportion of subjects free from any EDSS progression at week 48
    •Time to confirmed EDSS progression
    •Proportion of subjects free from confirmed EDSS progression at week 48
    •Mean number of new T1 gadolinium-enhancing lesions per subject per scan at week 48
    •Cumulative number of T1 gadolinium enhancing lesions at Week 48
    •Cumulative number of new CUA lesions at week 48
    •Mean number of CUA lesions per subject per scan at week 48
    •Mean change from baseline in the total volume of T2 lesions at week 48 (T2 Burden of disease) [mm³]
    •Proportion of subjects free from new T1-hypointense lesions (black holes) at week 48
    •Change in cognitive function at weeks 24 and 48 with respect to baseline as measured by Symbol Digit Modalities Test
    •Proportion of T1 gadolinium-enhancing lesions at Study Day 1 (SD1)
    that transform into black holes at week 48
    •Percent Brain Volume Change (PBVC) at week 48 with respect to baseline, and at week 96 with respect to week 48
    •Change from baseline in MSFC composite score at Weeks 12, 24, 36, 48
    •Time to first documented relapse
    •Annualized relapse rate at Weeks 48
    •Total number of reported relapses at all time points
    •Proportion of subjects treated with glucocorticoids due to relapses (during 48 weeks)
    •Proportion of subjects free from T1 gadolinium enhancing lesions at Week 48
    •Percentage of new T1-hypointense lesions (black holes) at Weeks 48 within the subgroup of new or enlarging non-enhancing T2
    lesions
    •Mean change from baseline in total volume of T1 hypointense lesions at Week 48 (in mm³)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As described in Section E.5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Denmark
    Estonia
    Finland
    Germany
    Italy
    Latvia
    Lithuania
    Netherlands
    Norway
    Portugal
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    For administrative and safety reporting purposes, the end of the trial will be defined as the date of the final clinical database lock after the last subject has completed the Week 48/96/Early Termination visit and the safety follow-up visit 12 weeks after, at Week 108. This provides for a single and conservative definition across all trial sites.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 230
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 230
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-22
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