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    Summary
    EudraCT Number:2016-003888-19
    Sponsor's Protocol Code Number:OSU6162DB003
    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:2017-01-03
    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 number2016-003888-19
    A.3Full title of the trial
    Double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of OSU6162 in the treatment of residual symptoms after stroke
    Dubbelblind, randomiserad, placebo-kontrollerad studie att utvärdera effekt och säkerhet hos OSU6162 av kvarvarande symptom efter stroke
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of OSU6162 in the treatment of residual symptoms after stroke
    Dubbelblind, randomiserad, placebo -kontrollerad studie att utvärdera effekt och säkerhet hos OSU6162 av kvarvarande symptom efter stroke
    A.4.1Sponsor's protocol code numberOSU6162DB003
    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 code431 37
    B.5.3.4CountrySweden
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameOSU6162
    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
    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
    Stroke
    Stroke
    E.1.1.1Medical condition in easily understood language
    Stroke
    Stroke
    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
    To evaluate the efficacy and safety of OSU6162 with respect to treatment response in post stroke patients
    Utvärdera effekten och säkerhet av OSU6162 gällande respons av behandling av stroke patienter
    E.2.2Secondary objectives of the trial
    Not applicable
    Inte relevant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed written informed consent
    2. Between 18-80 years
    3. Stroke >12 months prior to the start of the study. Patients must have had the location of their stroke evaluated through a CT scan, noted in their hospital notes
    4. Anamnestic evidence of post stroke residual symptoms at least 3 months prior to the start of the study
    5. At least 10.5 points on Mental Fatigue scale at the screening visit (week -2)
    1. Signerat samtycke
    2. Ålder 18-80
    3. Stroke >12 månader innan studiestart. CT scan gjord som visar var skadan är lokaliserad, dokumenterad i journalanteckning
    4. Diagnostiserad med kvarvarande symptom efter stroke >3 månader innan studiestart
    5. Minst 10.5 poäng på Mental Fatigue skattningsskala på screening besök (vecka -2)
    E.4Principal exclusion criteria
    1. Residual symptoms following other pathologies than stroke
    2. Active substance abuse (drug screen taken at visit1)
    3. Other serious somatic or psychiatric disease
    4. Beck Depression Inventory >30 at visit1 and 2
    5. Current pregnancy or breast-feeding, or intention to become pregnant within 3 months after the last dose
    6. Women of childbearing age not using contraceptives
    7. Pathologic ECG, as assessed by the investigator. Max QTc time on ECG: 451 ms in men and 460 ms in women
    8. Abnormal laboratory values of such severity that participation in the study, in the opinion of the investigator, is questionable
    9. Patients who are so debiliated by their disease that they are not assumed to be able to perform the assessments or handle the instruments used for evaluation of effect
    10. Current participation in other Clinical trials
    11. Previous treatment with OSU6162
    12. Clinically significant liver disease which may prevent the patient from completing the study and/or an elevation in either total bilirubin, alkaline phosphatase, LDH, SGOT of >2 times the laboratory reference
    13. Clinically significant renal disease which may prevent the patient from completing the study and/or an elevation in serum creatinine of >1.5 times the laboratory reference.
    14. Any surgical or medical condition which, in the opinion of the investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug
    15. Patients treated with Modiodal, Xyrem, Mirtazapine, Mianserin or metabolic enzyme inhibitors or inducers, or drugs with a narrow treatment window (e.g. warfarin, antiepileptics, cyclosporine) and individually modelled drugs such as lithium
    16. Use of drugs capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone) within 30 days prior to the start of the study (or 5 half-lives of the inducing agent, whichever is longer)
    17. Antipsychotic treatment
    18. Patients treated with “unstable therapies”, i.e., treatments that have not been at the same dose for at least 6 weeks prior to inclusion in this study. The treatment must also remain unchanged during the study period. Insomnia medication and other PRN medications are allowed
    19. Use of acute or chronic medications for other medical conditions are allowed based on the investigator's judgement. Occasional use of over-the-counter (OTC) medication is allowed at the investigator's discretion
    20. Supplements from Health food stors and naturopathic preparations are not allowed dusring the course of the study or 4 weeks fefore study start
    1 Kvarvarande symptom efter andra åkommor än stroke
    2 Drogmissbruk (drogtest utfört visit1)
    3 Andra somatiska or psykiatriska sjukdomar
    4 Becks depression skattning >30 visit1 och visit2
    5 Graviditet eller amning, eller intention att bli gravid inom 3 månader efter sista dos studieläkemedel
    6 Kvinnor i fertil ålder som inte använder preventivmedel
    7 Patologiskt ECG, bedömt av prövare. Max QTc tid på ECG: 451 ms för män och 460 ms för kvinnor
    8 Onormala laboratorie värden av sådan alvarlighetsgrad att medverkande i studien är osäkert enligt bedömning av prövare
    9 Patienter som är så försvagad av sin sjukdom att dom inte anses kunna utföra det som studien kräver
    10 Medverkande i annan klinisk forskningsstudie
    11 Tidigare behandling med OSU6162
    12 Klinisk signifikant lever sjukdom som kanske inte tillåter patienten att kunna slutföra studien och /eller förhöjning i total Bilirubin, ALP, LDH, SGOT ASAT av >2 gånger referensvärde
    13 Klinisk signifikant njur sjukdom som kanske inte tillåter patienten att kunna slutföra studien och /eller förhöjning i serum Kreatinin av >1.5 gånger referensvärde
    14 Kirurgisk eller medicinsk åkomma som enligt prövaren enteragerar med upptag, distrubition, metabolism eller exkretion av studieläkemedlet
    15 Patienter behandlade med Modiodal, Xyrem, Mirtazpine, Mianserin eller metabol enzym hämmare eller igångsättare, eller läkemedel ett snävt behandlings fönster ( waran, antiepileptika, cyklosporin,) och litium
    16 Användande av läkemedel som kan framkalla lever enzym metabolism (barbutuates, rifampicin, carbamazepine, phenytoin, primidone) 30 dagar innan studiestart (eller 5 halverings tider av framkallande agenten, den som är längre)
    17 Patienter behandlade med ostabil medicinering, behandling som inte haft samma dos minst 6 veckor innan inklusion i studien. Behandlingen skall vara oförändrad genom studien. Sömnmedel och andra vid behovs medicinering är godkänt
    18 Patienter behandlade med ostabil medicinering, behandling som inte haft samma dos minst 6 veckor innan inklusion i studien. Behandlingen skall vara oförändrad genom studien. Sömnmedel och andra vid behovs medicinering är godkänt
    19 Användande av akut eller kronisk medicin för andra medicinska sjukdomar är tillåtna utifrån prövarens beslut.
    20 Kosttillskott från hälsobutiker; naturläkemedelär inte tillåtet genom studien eller 4 veckor innan studiestart
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints will be change from baseline in total score on Clinical Global Impression of Change (CGI-C) after 16 weeks of treatment with OSU6162or placebo, with data Collection at baseline, week 4, 8, 12 and 16.
    Primära endpoints:
    Förändringar från baseline i totalvärde för Clinical Global Impression of Change (CGI-C) efter 16 veckors behandling med OSU6162 eller placebo med data insamling från baseline, vecka4, 8, 12 och 16.
    E.5.2Secondary end point(s)
    Mental Fatigue Scale (MFS)
    Fatigue Severity Scale (FSS)
    Becks Depression Inventory (BDI)
    Frenchay Activity Index (FAI)
    SF-36
    Stroke Impact Scale (SIS)
    after 4, 8, 12 and 16 weeks treatment.
    - Plasmakoncentration of OSU6162 after 4 and 16 weeks treatment
    - Vital signs and blood and urine samples at screening/baseline and after 4, 8, 12 and 16 weeks of treatment
    - Physical and neurological examinations
    - Adverse Event
    Mental Fatigue Scale (MFS)
    Fatigue Severity Scale (FSS)
    Becks Depression Inventory (BDI)
    Frenchay Activity Index (FAI)
    SF-36
    Stroke Impact Scale (SIS)
    efter 4, 8, 12 och 16 veckors behandling.
    - Plasmakoncentration med OSU6162 efter 4 och 16 veckors behandling
    - Vital signs and blod and urin analys screening/baseline och efter 4, 8, 12 och 16 veckors behandling
    - Fysisk and neurologisk undersökningar
    - Adverse Event
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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) 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.8.4.1Number of sites anticipated in Member State concerned1
    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 years5
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-01-03. Yes
    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 state100
    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 study, all patients will return to ordinary medical care.
    Efter studien kommer alla patienter återgå till ordinarie vård.
    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 Decision2017-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-04-30
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