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    Summary
    EudraCT Number:2010-020328-23
    Sponsor's Protocol Code Number:EMR 200136-532
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-07
    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 ConcernedItaly - Italian Medicines Agency
    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 REBIF (SOLAR)
    A.3.2Name or abbreviated title of the trial where available
    SOLAR
    A.4.1Sponsor's protocol code numberEMR 200136-532
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMERCK SERONO SA
    B.1.3.4CountrySwitzerland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 OIL
    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.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    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 (WEEK 96) - TO EXPLORE PHARMACOGENETICS / PHARMACOGENOMICS (PGx) 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
    1. Be males or females between 18 and 50 years of age 2. Have relapsing-remitting form of MS, according to the revised McDonald criteria 2005 3. Have brain and/or spinal MRI with findings typical of MS 4. Have had the first clinical event within 5 years prior to Screening 5. Have experienced at least one clinical event or one Gd-enhancing MRI lesion in the last 12 months before the Screening visit 6. Have score  4.0 on the EDSS at Screening 7. Currently and for the first time treated with interferon-beta-1a (tiw) s.c., and having received this treatment a minimum of 90 days and for not longer than 12 months before baseline visit (including titration period) 8. Be willing and able to comply with the protocol 9. Provide written informed consent prior to any trial related procedures
    E.4Principal exclusion criteria
    1. Pregnancy and lactation period 2. Any disease other than MS that could better explain signs and symptoms. 3. Complete transverse myelitis or bilateral optic neuritis. 4. 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. 5. Use of any cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure within 12 months prior to Screening. 6. Use of oral or systemic corticosteroids or ACTH within 30 days prior to the SD1 visit. 7. Have experienced a relapse within 30 days before the SD1 visit 8. Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, e.g. primary hyperparathyroidism or granulomatous disorders. 9. Have a urine calcium/creatinine (mmol/mmol) ratio greater than 1.0 or hypercalcaemia (11 mg/100cc (5.5 mEq./l.). 10. Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides. 11. Are taking more than 400 IU (10 �g) of Vitamin D supplement daily. 12. 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. 13. Have inadequate liver function, defined by alanine aminotransferase (ALT) > 3 times upper limit of normal (ULN), aspartate aminotransferase (AST) > 3 times upper limit of normal (ULN)or alkaline phosphatase > 2.5 times ULN, or total bilirubin > 1.5 times ULN, if associated with any elevation of ALT or alkaline phosphatase 14. Moderate to severe renal impairment (estimate of glomerular filtration rate [GFR] < 50 mL/min/1.73 m2 [based on creatinine clearance according to Cockcroft-Gault equation]) 15. Inadequate bone marrow reserve, defined by a WBC count < 0.5 times the lower limit of normal. 16. 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). 17. History or presence of severe depression, history of suicide attempt, or current suicidal ideation. 18. Epilepsy or seizures not adequately controlled by treatment. 19. Current or past (within the last 2 years) alcohol or drug abuse. 20. 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. 21. Known contra-indication to treatment with vitamin D (according to SPC) 22. Known hypersensitivity to IFN or its excipient(s) (according to SPC). 23. Known hypersensitivity to gadolinium. 24. Any other condition that would prevent the subject from undergoing an MRI scan. 25. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. 26. Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening). 27. Legal incapacity or limited legal capacity. 28. Another current autoimmune disease, except diabetes.
    E.5 End points
    E.5.1Primary end point(s)
    THE PRIMARY ENDPOINT IS A COMPOSITE ENDPOINT OF MRI AND CLINICAL VARIABLES: - THE PRIMARY MRI ENDOPOINT IS THE MEAN CHANGE FROM BASELINE IN THE TOTAL VOLUME OF T2 LESIONS AT WEEK 48 - THE PRIMARY CLINICAL ENDPOINT IS THE PROPORTION OF RELAPSE-FREE PATIENTS AT WEEK 96
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    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 EEA53
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    Data chiusura finale del database. For safety/administrative reasons, it is date of the final clinical database lock after the last subject has completed the Week 96/Early Termin vis and the safety follow-up vis 4 weeks after, at Week 100
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 358
    F.4.2.2In the whole clinical trial 358
    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)
    After the subject has completed the trial or has withdrawn early, usual treatment will be administered, if required, in accordance with the trial site’s standard of care and generally accepted medical practice and depending on the subject’s individual medical needs.
    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 Decision2011-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-05
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