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    Summary
    EudraCT Number:2009-015928-28
    Sponsor's Protocol Code Number:ELTODYS09
    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:2010-08-13
    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 number2009-015928-28
    A.3Full title of the trial
    A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease.
    A.3.2Name or abbreviated title of the trial where available
    ELTODYS09
    A.4.1Sponsor's protocol code numberELTODYS09
    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 SponsorPsychoGenics Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 nameEltoprazine HCl
    D.3.2Product code Eltoprazine HCl
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) 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 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
    Dyskinesias related to levodopa treatment in Parkinson´s disease
    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 determine the effective dose of eltoprazine HCl on the suppression of dyskinesias in L-dopa treated patients while sustaining the normal treatment effect of L-Dopa.
    E.2.2Secondary objectives of the trial
    To assess the safety & tolerability of eltoprazine HCl in adults with Parkinson’s Disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Parkinson’s disease, defined according to the UK Brain Bank Criteria. Bradykinesia should be combined with one of resting tremor, rigidity or postural imbalance.
    - Duration of L-dopa treatment of at least 3 years.
    - Significant dyskinesias after L-dopa dosages according to clinical experience.
    - Significant dyskinesias in a screening single dose L-dopa challenge using two
    dyskinesia rating scales. The screening test is performed with a challenge dose of 150% of the normal regular dose of L-Dopa the patient is about to take at the time of testing. If no dyskinesias appear during the first challenge, the challenge may be repeated on an alternate day (and) significant dyskinesias in a patient self-administered diary with 3 levels with 3 grades (off, on without dyskinesias, on with hyperkinesias) after the challenge dose has been given. Patients can be included if one of the two challenge tests are positive and diary is positive for dyskinesias.
    - Over 18 years of age.
    - This inclusion criterion (2) applied to females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) only. Must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives or Norplant; a reliable barrier method of birth control diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) during the study.
    - Signed informed consent.
    - Must be able to communicate effectively with the investigator and study coordinator.
    E.4Principal exclusion criteria
    - Exclusion criteria for Parkinson’s disease according to the UK Brain Bank Criteria for Parkinson’s disease.
    - Fulfillment of any other atypical parkinsonism diagnosis according to published criteria for multiple system atrophy, progressive supranucelar paresis, dementia with Lewy body, corticobasal gangliotic disease and dementia with Parkinson’s disease.
    - Any suspected secondary parkinsonism: drug induced parkinsonism; toxin-induced parkinsonism; trauma-induced parkinsonism; normal pressure hydrocephalus and vascular parkinsonism.
    - Ongoing treatment with any anti-dopaminergic medications (neuroleptics) for the past 6 months.
    - Ongoing treatment with any selective serotonin re-uptake inhibitors (SSRI) for the past 4 weeks.
    - Ongoing treatment with any combined norepinephrine and serotonin re-uptake inhibitors (SNSRI) for the past 4 weeks.
    - Significant depression defined as > 18 in the Montgomery Åsberg Depression Rating Scale combined with a clinical evaluation as to any clinical relevant depression.
    - Pregnancy or breast-feeding.
    - Reduced kidney function; defined as a creatinine level > 120 umol/L.
    - Reduced liver function, defined as ASAT >1,0 ukat/L, or ALAT > 1,0 ukat/L, or GT > 1,6 ukat/L, or total bilirubin> 30 umol/L, eller ALP> 6,0 ukat/L.
    - History of any other medical condition thought to interfere with the study or study medication (i.e., recent myocardial infarction, uncontrolled diabetes, uncontrolled hypertension (systolic blood pressure > 180 mmHg), ongoing severe infection).
    - Receipt of an investigational drug within 30 days or 5 half-lives of the drug, whichever is longer, prior to entering this study.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the effective dose of eltoprazine on the suppression of dyskinesias in L-dopa treated patients while sustaining the normal treatment effect of L-Dopa using the following efficacy measures:

    - Change in the highest observed Unified Parkinson’s Disease Rating Scale (UPDRS) III prior to and after study medication is given, to indicate a deterioration of the normal treatment effect of L-dopa.
    - Population mean values for the change in dyskinesias ratings between the placebo and screening baseline values and any of the eltoprazine dosages used, calculated as the area-under-the-curve, AuC, for the CDRS ratings over 3 hours after L-dopa and study medication intake.
    - Population mean values for the change in dyskinesias ratings between the placebo and screening baseline values and any of the eltoprazine dosages used for the peak of dose for Rush DRS ratings over 3 hours after L-dopa and study medication intake.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 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 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 concerned2
    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
    The last visit of the last subject undergoing the trial.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 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 2010-08-13. 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2010-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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