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    Summary
    EudraCT Number:2009-015926-13
    Sponsor's Protocol Code Number:HD 01/09
    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:2009-12-04
    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 number2009-015926-13
    A.3Full title of the trial
    Treatment of Huntington´s disease with OSU 6162 - a pilot study
    A.4.1Sponsor's protocol code numberHD 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 SponsorSahlgrenska University Hospital
    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 Yes
    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 146798-6665
    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 Information not present in EudraCT
    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
    Patients with Huntington´s disease
    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
    The study will be conducted in order to investigate the effect of OSU 6162 on Huntington´s disease and the safety of this product in 24 patients (men and women) who have Huntington´s disease diagnosed in a clinical investigation and confirmed in a molecular genetic test. .
    E.2.2Secondary objectives of the trial
    There is no secondary objective
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who have Huntington´s disease diagnosed in a clinical investigation and this has been confirmed in a molecular genetic test showing a CAG repeat length in the range of 39 - 50 repeats.
    2. In the total functional capacity scale (TFC) the patients will have between 3 and 13 points indicating that the disease has not reached the two most severe stages. TFC consists of estimations on 5 variables; engagement in occupation, capacity to handle financial affairs, capacity to manage domestic responsibilities, capacity to perform activities of daily living, and in which setting the care of the patient can be provided. Each item can be given 0 to 2 or 3 points according to the importance of the item. Zero points are given when the patient has no or very poor function on a specific item. The sum of all items gives an estimation of the functional capacity of the patient. TFC is the best measurement available to evaluate the progress of all aspects of the diseases (motor, behavioral and cognitive).
    3. Signed informed consent by patients.
    4. If the general cognitive function of the patient is considered to be mildly impaired an informed consent will also be signed by a close relative living together with the patie
    E.4Principal exclusion criteria
    1. Significant co-morbidity and alcohol or drug abuse.
    2. Pregnant women.
    3. Women of childbearing age not on contraceptives.
    4. Patients with a disease so severe that a legal representative is necessary.
    5. 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.
    6. Clinically significant liver and/or an elevation in either total bilirubin, alkaline phosphatase, LDH, SGOT above the laboratory reference. Clinically significant renal disease and/or an elevation in serum creatinine above the laboratory reference.
    7. Presence of active neoplastic disease.
    8. Patients who have had electroconvulsive therapy within 90 days.
    9. 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.
    10. 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) before the enrollment in this study.
    11. Patients with a medical history of seizures.
    12. Unstable therapies are not allowed but stable therapies are allowed. A stable therapy is defined as having started at least 4 weeks before the study and continued to be unchanged during the study period. Examples of stable therapies on neuroleptics are: haloperidol or risperidon (highest allowed dose 3 mg/daily); antidepressant therapy such as citalopram (highest allowed dose 40 mg/daily), mirtazapin (higest allowed dose 45 mg daily) or sertraline (higest allowed dose 100 mg/daily). Other stable therapies with hypnotics and anxiolytics are also allowed if they are given at doses recommend by the manufactures. Analgetics such as NSAID, acetyl salicylic acid and paracetamol are permitted.
    13. Use of acute or chronic medications for other medical conditions are allowed based on clinical judgment. Occasional use of over-the-counter (OTC) medications is allowed at the investigator's discretion. All concomitant medications, whether OTC or prescription, are required to be noted on the Concomitant Medication from.
    14. Tetrabenazine is not permitted during the study and the wash out period before the study is 4 weeks.
    15. Suicidal patients according to the clinical estimation or more than 2 points on item 9 of the Beck Depression Inventroy (BDI) scale are excluded.
    16. Abnormal laboratory parameters such as: Hemoglobine, white blood cells count, electrolytes, TSH, T4, B12, folic acid. All levels above the laboratory references level are considered abnormal.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is to investigate the therapeutic effects of OSU 6162 as measured by the motor, cognitive, behavior and functional protocol used in Registry 2005 which is a slight modification from the Unified Huntington Disease Rating Scale (UHDRS 1996). The Trail Making test A will also be used.
    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 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 Yes
    E.7.1.3.1Other trial type description
    An exploratory, pilot study in patients
    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 Yes
    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
    Last visit will be 12 weeks after the first.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    Continued care as before the trail
    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 Opinion2010-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
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