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    Summary
    EudraCT Number:2013-002545-10
    Sponsor's Protocol Code Number:OSU6162Open1309
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-11
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-002545-10
    A.3Full title of the trial
    An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.
    En öppen studie av säkerhet hos den monoaminerga stabiliseraren (-)-OSU6162 hos patienter med mental trötthet och därmed relaterad vitalitets- och vakenhetsstörning registrerade vid neuro-psykiatriska sjukdomar som Parkinsons sjukdom, Huntingtons sjukdom, traumatisk hjärnskada, stroke, Myalgisk encefalomyelit och narkolepsi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.
    En öppen studie av säkerhet hos den monoaminerga stabiliseraren (-)-OSU6162 hos patienter med mental trötthet och därmed relaterad vitalitets- och vakenhetsstörning registrerade vid neuro-psykiatriska sjukdomar som Parkinsons sjukdom, Huntingtons sjukdom, traumatisk hjärnskada, stroke, Myalgisk encefalomyelit och narkolepsi.
    A.3.2Name or abbreviated title of the trial where available
    OSU6162Open1309
    A.4.1Sponsor's protocol code numberOSU6162Open1309
    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 SponsorA. Carlsson Research AB
    B.1.3.4CountrySweden
    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 supportA. Carlsson Research AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGottfries Clinic AB
    B.5.2Functional name of contact pointC.G. Gottfries
    B.5.3 Address:
    B.5.3.1Street AddressKrokslätts Torg 5
    B.5.3.2Town/ cityMölndal
    B.5.3.3Post codeSE 431 37
    B.5.3.4CountrySweden
    B.5.4Telephone number+46313432397
    B.5.5Fax number+4631209938
    B.5.6E-mailcgg@gottfries.se
    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 No
    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.3.2Product code OSU6162 similar to (-)-OSU 6162
    D.3.4Pharmaceutical form Coated 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinsons disease
    Huntingtons disease
    Multiple scleros
    Brain trauma
    Stroke
    Myalgic encephalomyelitis
    Narcolepsy
    Parkinsons sjukdom
    Huntingtons sjukdom
    Multipel scleros
    Traumatisk hjärnskada
    Stroke
    Myalgisk encefalomyelit
    Narkolepsi
    E.1.1.1Medical condition in easily understood language
    Parkinsons disease
    Huntingtons disease
    Multiple scleros
    Brain trauma
    Stroke
    Myalgic encephalomyelitis
    Narcolepsy
    Parkinsons sjukdom
    Huntingtons sjukdom
    Multipel scleros
    Traumatisk hjärnskada
    Stroke
    Myalgisk encefalomyelit
    Narkolepsi
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.
    En öppen studie av säkerhet hos den monoaminerga stabiliseraren (-)-OSU6162 hos patienter med mental trötthet och därmed relaterad vitalitets- och vakenhetsstörning registrerade vid neuro-psykiatriska sjukdomar som Parkinsons sjukdom, Huntingtons sjukdom, traumatisk hjärnskada, stroke, Myalgisk encefalomyelit och narkolepsi.
    E.2.2Secondary objectives of the trial
    We will also explore the value of new objective measuring methods
    concerning movement patterns and level of activitry.
    Vi kommer också att explorera värdet av nya objektiva mättekniker
    med avseende på rörelsemönster och aktiveringsgrad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient should sign informed consent.
    Should be 18-75 years old.
    Women of child bearing age should be on contraceptives. Patients with brain trauma and stroke should have a minimal time period of 12 months since onset/diagnosis and a minimal of three months fatigue.
    Patients should fulfil international criterias for one of the diseases listed in the project title.
    Patienten skall ha undertecknat informerat samtycke till deltagande i studien, ska vara mellan 18 och 75 år.
    Kvinna i fertil ålder skall ha tillförlitlig antikonception, dvs P-stav, P-spruta, sterilisering, hormonspiral, kopparspiral, kondom, p-piller. Traumatisk hjärnskada och stroke ska ha en minimal tidsperiod sedan insjuknande/diagnos på 12 månader och trötthet i minst tre månader.
    Patienten ska också uppfylla internationellt gällande kriterier för någon av de diagnoser som anges i projektets titel.
    E.4Principal exclusion criteria
    Patients with unstable medication.
    Patients with abuse problems.
    Patients suffering from other serious somatic or psychiatric diseases.
    Becks depression scale 30 points or more at V1 och V2
    Pregnant women (pregnancy test V1 and V7).
    Breast feeding women.
    Patients with aberrant laboratory investigations of serious degree.
    Pathological ECG
    Maximal QTc on ECG: 450 ms for men and 460 ms for women.
    Pathological UCG heart.
    Patients mentally or somatically reduced so they can not participate in
    ratings or other methods for evaluating effect.
    Patients receiving therapy with Modiodal, Xyrem , mirtazapin, metabolic enzyme inhibitors, metabolic enzyme inducers and drugs with a narrow therapeutic window (i.e. warfarine, antieoileptics , cyclosporine, tacrolimus, individually dose titrated drugs i.e. lithium) are excluded.
    Patients should not participate in any other Clinical studies.
    Om patienten erhåller annan behandling under inställning
    Patienter med missbruksproblem (drogtest tas vid V1)
    Om patienten lider av annan allvarlig somatisk eller psykiatrisk sjukdom
    Becks depression scale max 30 poäng eller mer vid V1 och V2
    Gravida kvinnor (graviditetstest tas vid V1 och V7)
    Kvinnor som ammar
    Patienter med abnorma laboratorievärden av sådan allvarlighetsgrad att deltagandet i studien kan ifrågasättas
    Patologiskt EKG
    Max QTc-tid på EKG: 450 ms hos män och 460 ms hos kvinnor
    Patologiskt hjärt-ultraljud
    Patienter som bedöms vara så invalidiserade av sin sjukdom att de inte antas klara av skattningsförfarandet eller att hantera instrument för urvärdering av effekt
    Patienter som behandlas med läkemedlen Modiodal, Xyrem, mirtazapin samt metabolic enzyme inhibitors, metabolic enzyme inducers och läkemdel med ett smalt terapeutiskt fönster (tex. warfarin, antiepileptika, cyklosporin, tackolimus och individuellt inställda lälkemedel såsom litium).
    Patienter får inte samtidigt delta i andra forskningsstudier.


    E.5 End points
    E.5.1Primary end point(s)
    Safety of OSU6162. Recording of adverse events on doses between 5 - 90 mg per
    day in patients with Parkinson's disease, Huntington's disease,multiple sclerosis,brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.

    OSU6162:s säkerhet.
    Registrering av AE vid behandling med doserna 5 - 90 mg dagligen av patienter med Parkinsons sjukdom, Huntingtons sjukdom, multipel skleros, traumatisk hjärnskada, stroke, myalgisk encefalomyelit och narkolepsi.

    E.5.1.1Timepoint(s) of evaluation of this end point
    After three months open study. (6 and 12 months for stroke).
    Efter tre månaders öppen studie. (6 och 12 månader för stroke)
    E.5.2Secondary end point(s)
    We will also explore the value of objective new techniques for measuring
    movements and activity levels before and after three months treatment (6 and 12 months for stroke).
    Vi kommer också att explorera värdet av nya mättekniker
    med avseende på rörelsemönster och aktiveringsgrad före
    och efter tre månaders behandling (6 och 12 månaders behandling vid stroke).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Three months open study (6 and 12 months for stroke).
    Tre månaders öppen studie (6 och 12 månader för stroke).
    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 No
    E.6.4Safety Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Compare the validity of ratings with the result of more objective instruments for
    mesuring activity variables.
    Jämföra tillförlitligheten av skattningar med resultat av objektiv mätning
    av aktivitet.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    öppen
    open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    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
    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 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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state240
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 240
    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
    Inga
    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 Decision2014-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-12-19
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