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    Summary
    EudraCT Number:2011-002969-38
    Sponsor's Protocol Code Number:CFTY720DDE07
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-002969-38
    A.3Full title of the trial
    A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 6-month, multicenter, randomized, controlled parallel group study to evaluate the effect of physical training on fatigue in patients with relapsing-remitting multiple sclerosis treated with fingolimod (Gilenya®), followed by a 6 month optional extension phase
    A.4.1Sponsor's protocol code numberCFTY720DDE07
    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 SponsorNovartis Pharma GmbH
    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 supportNovartis pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointProject Leader
    B.5.3 Address:
    B.5.3.1Street AddressRoonstr. 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number004991127313135
    B.5.5Fax number004991127317135
    B.5.6E-mailkatrin.schuh@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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 Gilenya
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameFingolimod
    D.3.2Product code FTY720
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 162359-56-0
    D.3.9.2Current sponsor codeFTY720
    D.3.9.3Other descriptive nameFingolimod Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fatigue in Patients with relapsing remitting Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    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 14.1
    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 evaluate the effect of structured physical e-training vs. no training on fatigue in Gilenya-treated RRMS patients after 6 months; assessed by the mFIS fatigue scale.

    E.2.2Secondary objectives of the trial
    • To evaluate the effect of structured physical e-training vs. no training on isometric and dynamic muscular strength measured by Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension) and sit-to-stand-test.
    • To evaluate the effect of structured physical e-training vs. no training on quality of life assessed by Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)
    • To evaluate the effect of structured physical e-training vs. no training on fatigue parameters assessed by the WEIMuS
    • To evaluate the effect of structured physical e-training vs. no training on depression assessed by the BDI-II
    • To evaluate the effect of structured physical e-training vs. no training on aerobic capacity measured by a graded exercise test on a treadmill using spiroergometry
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed.
    2. Male or female subjects aged 18-65 years.
    3. Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria (see Appendix 5).
    4. Patients with Expanded Disability Status Scale (EDSS) score of 0-3.5 (including) (see Appendix 7).
    5. Immunomodulatory treatment with prescribed fingolimod for at least one month prior to baseline
    6. Fatigue score assessed by mFIS of equal or greater than 14 at screening
    7. Willingness to participate in a structured interventional training program according to the study protocol
    8. Neurologically stable with no evidence of relapse within 30 days prior to inclusion date
    9. Sufficient ability to read, to write, to understand, to communicate also electronically, and to have access to world wide web.
    E.4Principal exclusion criteria
    1. Patients who have been treated with:
    • systemic corticosteroids or immunoglobulins within 1 month prior to randomization;
    • immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months prior to randomization;
    • monoclonal antibodies (including natalizumab) within 3 months prior to randomization;
    • mitoxantrone within 6 months prior to randomization
    • cladribine at any time.
    2. Patients with any medically unstable condition, as assessed by the primary treating physician at each site.
    3. Patients with any of the following cardiovascular conditions :
    • history of cardiac arrest;
    • history of myocardial infarction or with current unstable ischemic heart disease;
    • history of angina pectoris due to coronary spasm or history of Raynaud syndrome
    • Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the
    investigator;
    • history or presence of a second-degree AV block, Type II or a third-degree AV
    Blockor an increased QTc interval >450 ms in males and in females corrected using
    Bazett’s formula.
    • patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or
    III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide,
    dofelitide);
    • patients receiving beta-blockers
    • proven history of sick sinus syndrome or sino-atrial heart block;History of symptomatic bradycardia or recurrent syncope, cerebrovascular disease, hypokalaemia, congestive heart failure or severe sleep apnea
    • uncontrolled hypertension
    • resting heart reate 􀵑 45 bpm
    4. Patients with severe respiratory disease, pulmonary fibrosis, or chronic obstructive
    pulmonary disease (Class III-IV).
    5. Patients with any of the following neurologic/psychiatric disorders:
    • current substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject’s ability to cooperate and comply with the study procedures;
    • progressive neurological disorder, other than MS, which may affect participation in the study.
    6. Clinically relevant internal disease (e.g. uncorrected anemia) or orthopedic diseases (e.g. scoliosis) that might interfere with physical training
    7. Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator`s discretion
    8. Patients who have received an investigational drug (excluding fingolimod) or therapy within 90 days or 5 half-lives of randomization, whichever is longer.
    9. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory

    E.5 End points
    E.5.1Primary end point(s)
    To decrease the level of fatigue via a structured physical e-training vs. no training in Gilenya-treated RRMS patients after 6 months; assessed by the mFIS fatigue scale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 6 and 12 months
    E.5.2Secondary end point(s)
    • To evaluate the effect of structured physical e-training vs. no training on isometric and dynamic muscular strength measured by Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension) and sit-to-stand-test.
    • To evaluate the effect of structured physical e-training vs. no training on quality of life assessed by Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)
    • To evaluate the effect of structured physical e-training vs. no training on fatigue parameters assessed by the WEIMuS
    • To evaluate the effect of structured physical e-training vs. no training on depression assessed by the BDI-II
    • To evaluate the effect of structured physical e-training vs. no training on aerobic capacity measured by a graded exercise test on a treadmill using spiroergometry
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 6 and 12 months
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Training versus waiting group with delayed start of training after 6 months
    E.8.2.4Number of treatment arms in the trial2
    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 concerned38
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 226
    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 state226
    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)
    The investigator decides about further treament after the end of the study in the best interest of the patient. Gilenya is commercially available.
    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 Decision2011-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-14
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