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    Summary
    EudraCT Number:2012-003418-15
    Sponsor's Protocol Code Number:SSP
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-11-09
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-003418-15
    A.3Full title of the trial
    Methylphenidate modified release as treatment option of MS-associated fatigue. A single-center randomized double-blind placebo-controlled trial.
    Retardiertes Methylphenidat als Behandlungsoption bei MS-assoziierter Fatigue. Eine unizentrische, randomisierte, placebo-kontrollierte
    Doppelblindstudie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Methylphenidate modified release as treatment of MS-associated fatigue.
    Retardiertes Methylphenidat als Behandlung der MS-assoziierten Fatigue.
    A.4.1Sponsor's protocol code numberSSP
    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 SponsorMedizinische Universität Wien
    B.1.3.4CountryAustria
    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 supportUniversitätsklinik für Neurologie, Medizinische Universität Wien
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWiener Pflege-,Patientinnen-und Patientenanwaltschaft
    B.5.2Functional name of contact pointInformationsstelle
    B.5.3 Address:
    B.5.3.1Street AddressSchönbrunnerstr. 108, Eingang Sterkgasse
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1050
    B.5.3.4CountryAustria
    B.5.6E-mailpost@wpa.wien.gv.at
    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 Ritalin LA 20mg capsules
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameMethylphenidate modified release 20 mg
    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.3.8INN - Proposed INNMETHYLPHENIDATE HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 2
    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 Ritalin LA 30mg capsules
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameMethylphenidate modified release 30 mg
    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.3.8INN - Proposed INNMETHYLPHENIDATE HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 3
    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 Ritalin LA 40mg capsules
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameMethylphenidate modified release 40 mg
    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.3.8INN - Proposed INNMETHYLPHENIDATE HYDROCHLORIDE
    D.3.9.1CAS number 298-59-9
    D.3.9.4EV Substance CodeSUB03254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCapsule, hard
    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
    Fatigue is a very common symptom in multiple sclerosis. Its management comprises nonpharmacologic approaches like exercise, cooling procedures and energy conservation programs and as second step pharmacologic therapy. Until now, Amantadine, Modafinil or antidepressants have been used off-label among others, with some success. Until now, methylphenidate has been successfully used to treat fatigue in HIV
    and parkinson´s disease, data on its efficacy in MS are not available.
    Für die Therapie der bei Multipler Sklerose häufigen Fatigue stehen wenige Maßnahmen zur Verfügung. Zuerst werden den Patienten konservative Strategien empfohlen und der Einsatz von Medikamenten erfolgt erst sekundär.
    Folgende Medikamente können hilfreich
    sein (off-label): Amantadin,Modafinil oder Antidepressiva. Die Wirksamkeit von
    retardiertem Methylphenidat gegen Fatigue wurde bei Morbus Parkinson und HIV
    in Studien bestätigt. Zum Einsatz gegen MS-assoziierte Fatigue gibt es keine Daten.
    E.1.1.1Medical condition in easily understood language
    Fatigue is a common symptom in multiple sclerosis that is often difficult to treat. It is characterised by a physical and/or mental exhaustion.
    Bei Multipler Sklerose kommt es häufig zu einer verstärkten Ermüdbarkeit und Erschöpfbarkeit, deren medikamentöse Behandlung oftmals schwierig ist.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    The goal of our study is to determine the efficacy of methylphenidate in reducing fatigue in subjects with Multiple sclerosis. The question of whether MS‐associated fatigue improves after 6 weeks of methylphenidate therapy compared to baseline as measeured by Fatigue severity scale comprises the primary objective of our study.
    primärer Endpunkt: Verbesserung der Fatigue nach 6 Wochen Therapie gemessen anhand der Fatigue Severity Scale.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate the efficacy of methylphenidate on fatigue in subjects with MS as measured by MFIS (modified fatigue impact scale) and VAS (visual analogue scale), on quality of life as measured by HAQUAMS (Hamburger Lebensqualitätsfragebogen) and on quality of sleep as measured by Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index. An objetive assessment of fatigue will be done by neuropsychological TAP (test for attentional performance -subscale alertness and divided attention).
    sekundäre Endpunkte: Verbesserung von Fatigue nach 6 Wochen Therapie gemessen mittels modifizierter Fatigue Impact Scale und Visueller Analogskala. Weiters Einfluss auf die Lebensqualität erhoben mittels Hamburger Lebensqualitätsfragebogen und Einfluss auf Schlafqualität mittels Epworth Sleepiness Scale und Pittsburgh Sleep Quality Index. Objektive Beurteilung der Fatigue mittels neuropsychologischer Testbatterie (TAP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of multiple sclerosis (relapsing remitting, progressive
    courses) according to McDonalds criteria.
    • Age > 18years
    • Fatigue as measured by Fatigue Severity Scale
    • Signed informed consent
    Diagnose einer Multiplen Sklerose nach revidierten McDonalds Kriterien, Alter>18 Jahre, mittels Fatigue Severity Scale bestätigte Fatigue, unterschriebene Einverständniserklärung.
    E.4Principal exclusion criteria
    Known allergy or hypersensitivity to Methylphenidate or any of its
    ingredients.
    Marked anxiety, tension and agitation.
    Patients with glaucoma or hyperthyreodism.
    Patients with motor‐tics, a family history or diagnosis of Tourette´s
    Syndrom.
    Treatment with monoamine oxidase inhibitors, also within a
    minimum of 14 days following discontinuation (hypertensive crisis may result).
    Phaeochromocytoma.
    Pre‐existing cardiovascular disorders including severe hypertension, angina, arterial occlusive disorder, heart failure, haemodynamically significant congenital heart disease,
    cardiomyopathies, myocardial infarction, potentially lifethreatening
    arrhythmias and channelopathies.
    History of drug dependence or alcoholism.
    History of seizures.
    Severe psychiatric disorders.
    Pregnant women or females of childbearing potential who want to become pregnant within the study period.
    Change of any medication treatment <8 weeks before starting the study
    Participation in any other clinical trial at the same time
    E.5 End points
    E.5.1Primary end point(s)
    Improvement (baseline vs. 6 weeks) of fatigue as assessed by Fatigue Severity Scale
    Verbesserung der Fatigue (Baseline-6Wochen) gemessen mittels Fatigue Severity Scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and after six weeks of treatment with study medication
    Baseline und nach 6 Wochen Therapie
    E.5.2Secondary end point(s)
    Improvement of fatigue (baseline vs. 6 weeks) as assessed by modified
    fatigue impact scale.
    Improvement of fatigue (baseline vs. 6 weeks) as assessed by visual
    analogue scale.
    Improvement of quality of life (baseline vs. 6 weeks) as assessed by
    Hamburger Lebensqualitätsfragebogen.
    Improvement of fatigue as measured (baseline vs. 6 weeks) by
    neuropsycholgical TAP‐testing.
    Improvement of sleep quality (baseline vs. 6 weeks) as measured by
    ESS and PSQI
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and after six weeks of treatment with study medication
    Baseline und nach 6 Wochen Therapie
    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 Yes
    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 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
    If adverse events occur which are so serious that the risk‐benefit ratio is not acceptable.
    If the number of dropouts is so high that proper completion of the trial cannot realistically be
    expected.
    Bei Auftreten von schweren Nebenwirkungen, sodass das Nutzen-Risiko Profil nicht mehr akzeptabel ist.
    Bei einer unerwartet hohen Drop-out Quote, sodass die Studie realistischerweise nicht zu Ende geführt werden kann.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state96
    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
    keine
    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 Decision2012-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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