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    Summary
    EudraCT Number:2009-016360-37
    Sponsor's Protocol Code Number:PD 01/09
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-12-04
    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 ConcernedSweden - MPA
    A.2EudraCT number2009-016360-37
    A.3Full title of the trial
    TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY
    A.4.1Sponsor's protocol code numberPD 01/09
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBjörn Holmberg
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.1Product namenot available
    D.3.2Product code OSU 6162 similar to (-)-OSU 6162
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNnot available
    D.3.9.1CAS number 146798-66-5
    D.3.9.2Current sponsor codeOSU 6162 similar to (-)-OSU 6162
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCoated tablet
    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
    Parkinsons disease is complicated by dyskinesias and dystonia. Due stabilizing properties, we believe (-)-OSU6162 may alleviate dyskinesias, without causing parkinsonism. Aim: To evaluate in a double-blind cross over pilot study whether OSU6162 attenuates dyskinesias without worsening parkinsonism in PD patients with motor complications using clinical examination and patient diaries.
    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
    I. Primary
    Effects of treatement with OSU 6162 in advanced PD, measured as the difference between baseline and treatment week 4/8 on motor function, motor complications, and quality of life.
    The following tests will be performed:
    a. On-time without dyskinesia (patient diaries).
    b. Unified Parkinson's Disease Rating Scale (UPDRS) part IV (complications of treatment).
    c. Parkinson's Disease Quality of Life (PDQ 39).
    E.2.2Secondary objectives of the trial
    II. Secondary
    The difference between baseline and treatment week 4/8 on mental function, motor function, activities of daily living, and depressivity.
    The following tests will be performed:
    a. On-time with dyskinesia (patient diaries).
    b. Unified Parkinson's Disease Rating Scale (UPDRS) part I-III (mentation, activities of daily living and motor function, respectively), .including videorecordings of the UPDRS part III test.
    c. Beck Depression Inventory.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who fulfill the British Brain Bank diagnostic criteria for definite PD; 2. Long standing disease duration (more than 5 years); 3. Moderately disabling dyskinesias during at least 25% of the waking day, despite best medical treatment (UPDRS IV items no. 32 and 33 each ≥2). 4. Patient can rate on/off time and dyskinesias with at least a 66% concordance between patient and investigator/coordinator in a day in which patient experienced on with and without dyskinesias and off time. In order to be able to complete the home diaries, patients will be instructed in rating themselves in regard to on/off time and dyskinesias. This will be done at screening, before inclusion in the study, in a day in which the patient experiences on with and without dyskinesias and off time. Patients will spend in the clinic at least 4 hours or as long as needed, as judged by the investigator, during which time they will fill in the home diary form every hour, with the investigator performing the same evaluation concomitantly. Only patients eventually attaining at least a 66% concordance between their own and the assessment of the investigator/coordinator will be included in the study. 5. Subjects have signed the informed consent form.
    6. Stable antiparkinsonian and antidepressant medication during the last 4 weeks prior to inclusion in the study.
    E.4Principal exclusion criteria
    1. Significant co-morbidity including alcohol or drug abuse. Medical problems such as unstable or/and untreated ischemic cardiac disease, diabetes, hypertension, vitamin deficiencies, thyroid diseases.
    2. Pregnant women.
    3. Women of childbearing age not on contraceptives.
    4. Sick sinus syndrome; resting heart rate below 50 beats per minute; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of randomization; a prolonged QTc interval at screen or pretreatment (defined as a QTc interval of> 450 msec for males or> 470 msec for females); atrio-ventricular conduction block; other clinically significant heart conditions which would negatively impact on the patient completing the study.
    5. Clinically significant liver disease and/or an elevation in either total bilirubin, alkaline phosphatase, LDH, SGOT above the laboratory reference. Clinically significant renal disease which may prevent the patient from completing the study and/or an elevation in serum creatinine above the laboratory reference.
    6. Presence of active neoplastic disease.
    7. Patients who have had electroconvulsive therapy within 90 days.
    8. Patients with any surgical or medical condition which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug.
    9. Patients who are using drugs capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone) within the previous
    4 weeks (or 5 half lives of inducing agent, whichever is longer) of enrollment in this study.
    10. Patients with a medical history of seizures.
    11. Other medications as exclusion criteria:
    · Changes in patients’ antiparkinsonian or psychopharmaceutical treatment within 4 weeks before inclusion in the study or during the study is an exclusion criterion. Stable therapies implying that they are started at least 4 weeks before the inclusion in the study and continued unchanged during the study period are permitted. The following stable therapies are permitted: atypical neuroleptics such clozapine and quetiapine; antidepressant therapy; antiparkinsonian drugs; hypnotics and anxiolytics.
    · Tetrabenazine and amantadine treatment are not permitted during the study and the wash out period before the study must be at least 4 weeks, for a patient to be included.
    · Use of acute or chronic medications for other medical conditions is allowed based on clinical judgment . Occasional use of over-the-counter (OTC) medications is allowed at the investigator's discretion. Analgetics such as NSAIDs, acetyl salicylic acid and paracetamol are permitted.
    · All concomitant medications, whether OTC or prescription, are required to be noted on the Concomitant Medication Form.

    12. Untreated severe depression with a Beck Depression Inventory (BDI) score of 21 or more (Beck et al., 1961, 1996).
    13. Abnormal laboratory parameters such as: Hemoglobine, white blood cells count, electrolytes, TSH, T4, B12, folic acid. All levels above the laboratory references levels are considered abnormal.
    14. Suspicion of an atypical parkinsonian disorder.
    15. Dementia defined as a score of 27 or less on the Mini Mental Test Score (MMTS) (Folstein et al., 1975).
    16. Unsatisfactory communication with the patient due to language difficulties or unsatisfactory compliance with study protocol.
    17. Suicidal patients according to the clinical estimation or more than 2 points on item 9 of the BDI scale.
    E.5 End points
    E.5.1Primary end point(s)
    Effects of treatement with OSU 6162 in advanced PD, measured as the difference between baseline and treatment on motor function, motor complications, and quality of life.
    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 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) Yes
    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 Yes
    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.8.3 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 Information not present in EudraCT
    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
    End of trial is at last visit week 12
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) Yes
    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 state20
    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)
    Normal treatment
    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 Decision2010-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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