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    The EU Clinical Trials Register currently displays   35223   clinical trials with a EudraCT protocol, of which   5758   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-001253-13
    Sponsor's Protocol Code Number:ROCHIMS
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-11
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-001253-13
    A.3Full title of the trial
    Does cerebral hypoperfusion play a role in reduced axonal metabolism and clinical disability in patients with multiple sclerosis ?
    Speelt cerebrale hypoperfusie een rol in het verminderd axonaal metabolisme, de cognitieve achteruitgang en de vermoeidheid in patiënten met mulitple sclerose ?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does decresaed perfusion of the brain play a role in the reduced function of axons and the clinical disability and fatigue in patients with multiple sclerosis ?
    Speelt de verminderde doorbloeding van de hersenen een rol in een verminderde functie van de axonen, de cognitieve achteruitgang en vermoeiheid in patiënten met multiple sclerose ?
    A.3.2Name or abbreviated title of the trial where available
    ROCHIMS (Role of Cerebral Hypoperfusion In Multiple Sclerosis)
    A.4.1Sponsor's protocol code numberROCHIMS
    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 SponsorUZ Brussel
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCharcot Foundation
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportActelion Pharmaceuticals
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportUZ Brussel
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitair Ziekenhuis Brussel
    B.5.2Functional name of contact pointStephanie Hostenbach
    B.5.3 Address:
    B.5.3.1Street AddressLaarbeeklaan 101
    B.5.3.2Town/ cityJette
    B.5.3.3Post code1090
    B.5.3.4CountryBelgium
    B.5.6E-mailStephanie.Hostenbach@uzbrussel.be
    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 Tracleer
    D.2.1.1.2Name of the Marketing Authorisation holderActelion Pharmaceuticals Belgium
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboTablet
    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
    Patients suffering relapsing- remitting multiple sclerosis will be investigated in this study, with an EDSS score less or equal to 4.0. Patients must be older than 18 years old. There must not be any clinical evidence of an MS relpase within the 3 months prior to inclusion.
    Patiënten die lijden aan relapsing-remitting multiple sclerose zullen geïncludeerd worden in deze studie, met een EDSS score kleiner of gelijk aan 4. Patiënten moeten ouder zijn dan 18 jaar. Er mag geen klinische evidentie zijn voor het doorgemaakt hebben van een MS opstoot 3 maanden voorafgaand aan de inclusie.
    E.1.1.1Medical condition in easily understood language
    Patients with relapsing-remitting Multiple Sclerosis, older than 18 years old, who are clinically stable at the moment of inclusion.
    RRMS patiënten, ouder dan 18 jaar, die klinisch stabiel zijn op het moment van de inclusie.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cerebral perfusion is globally decreased in patients with Multiple Sclerosis (MS) and might contribute to progressive axonal degeneration, cognitive decline and fatigue. In this placebo-controlled, double-blind, randomized trial with the endothelin-1 antagonist bosentan, we want to explore whether pharmacological restoration of cerebral blood flow (CBF) in patients with MS can improve axonal metabolism and clinical disability.
    De cerebrale doorbloeding is globaal verlaagd in patiënten met Multiple Sclerose (MS) en kan op zijn beurt bijdragen tot de progressieve axonale degeneratie, cognitieve achteruitgang en vermoeidheid. In deze placebo-gecontrolleerde dubbel-blinde gerandomiseerde studie met de endotheline-1 antagonist bosentan, willen we graag nagaan of het pharmacologische herstel van de cerebrale blood flow (CBF) in patiënten met MS het axonaal metabolism en de klinische achteruitgang kan verbeteren.
    E.2.2Secondary objectives of the trial
    Not applicable.
    Niet van toepassing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with the diagnosis of relapsing-remitting MS, according to the 2010 Revised Mc Donald Criteria
    - Age > 18 years
    - Written informed consent must be obtained
    - EDSS score < or equal to 4
    E.4Principal exclusion criteria
    - Clinical evidence of MS relapse within 3 months prior to inclusion.
    - Known contra-indications for bosentan: liver dysfunction (AST and/or ALT > 3 x ULN), use of cyclosporine A and glibenclamide, allergy
    - Pregnancy
    E.5 End points
    E.5.1Primary end point(s)
    N-acetyl aspartate (NAA) levels after restoring the cerebral blood flow (CBF) with the endothelin-1 antagonist.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before the start of the study (day 0).
    At the end of the study (this is at day 28 +/- 2 days)
    E.5.2Secondary end point(s)
    - Effects on the clinical disability and fatigue in MS patients
    - Effects on biomarkers of multiple sclerosis (serum neurofilament light chain) wich can be used as a marker of axonal damage.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before the start of the study (day 0).
    At the end of the study (this is at day 28 +/- 2 days)
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 No
    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 trial2
    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 No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    The end of the trial is defined as the day where the last subject will undergo the last examens written in the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    None
    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 Decision2017-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-23
    P. End of Trial
    P.End of Trial StatusOngoing
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