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    Summary
    EudraCT Number:2017-000192-86
    Sponsor's Protocol Code Number:NMSNabStudy
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-10
    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 ConcernedAustria - BASG
    A.2EudraCT number2017-000192-86
    A.3Full title of the trial
    Nabilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study
    Nabilon für nicht-motorische Symptome bei der Parkinson-Krankheit: Eine randomisierte, placebo-kontrollierte, doppelblinde, in Parallelgruppen ablaufende Entzugsstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-motor symptoms (e.g.sleeping disorders,cognitive dysfunction, hallucinations, autonomic dysfunction including urinary incontinence, constipation,...)
    A.4.1Sponsor's protocol code numberNMSNabStudy
    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 SponsorMedizinische Universität Innsbruck, Universitätsklinik für Neurologie
    B.1.3.4CountryAustria
    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 supportAOP Orphan Pharmaceuticals AG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Innsbruck, Universitätsklinik für Neurologie
    B.5.2Functional name of contact pointClinical Trial Center Neurology
    B.5.3 Address:
    B.5.3.1Street AddressAnichstraße 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post codeA-6020
    B.5.3.4CountryAustria
    B.5.4Telephone number+4351250425810
    B.5.5Fax number+4351250425819
    B.5.6E-mailraphaela.stolz@tirol-kliniken.at
    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 nameNabilone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNNABILONE
    D.3.9.1CAS number 51022-71-0
    D.3.9.4EV Substance CodeSUB09104MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 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
    Subjects with non-motor symptoms of Parkinson´s disease
    E.1.1.1Medical condition in easily understood language
    Parkinson´s disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy objective of this study is to demonstrate the efficacy of nabilone concerning non-motor symptoms of patients with Parkinson´s disease, based on the change from baseline to Week 4/Termination visit in the MDS-UPDRS Part I.
    E.2.2Secondary objectives of the trial
    to evaluate the effect of nabilone on motor symptoms of PD and on different domains of NMS by means of the change from baseline to Week 4 in the following assessments:

    MDS – Unified Parkinson´s Disease Rating Scale
    Non Motor Symptoms Scale
    mood/anxiety domain of MDS-UPDRS Part I (items 1.3 and 1.4)
    different other domains of NMSS & MDS-UPDRS part I
    Hospital anxiety and depression scale
    Parkinson´s Disease Questionnaire – 39
    Montreal Cognitive Assessment
    Epworth Sleepiness Scale
    Fatigue Severity Scale
    Visual Analog Scale of Pain
    King's Parkinson's disease pain scale
    Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease–Rating Scale

    Clinical Global Impression – Global Improvement scale at Termination Visit


    Safety and Tolerability objectives on the Overall course of the study

    Exploratory Objective: Eye-tracking evaluation in PD patients taking nabilone or placebo at the Screening and the Termination visit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age ≥30 years
    2.Diagnosis of PD: PD should be either de novo or on stable medication without disturbing motor fluctuations or dyskinesia.
    3.NMS with a score of ≥4 on MDS-UPDRS Part 1. One of the following domains have to be affected with a score ≥2: 1.4 (anxious mood) or 1.9 (pain)
    4.On a stable regimen of anti-parkinson medications for at least 30 days prior to screening and willing to continue the same doses and regimens during study participation
    5.Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to screening, and subject must be willing to continue the same doses and regimens during study participation
    6.Patient is informed and had enough time and opportunity to think about his/her participation in the study and has signed a current IRB-approved informed consent form
    7.Contraception
    a.Women of childbearing potential must use or attest an acceptable method* of contraception starting 4 weeks prior to study drug administration and for a minimum of 1 month after study completion.
    b.Men with a potentially fertile partner must be willing to use an acceptable method* of contraception for the duration of the study and for 3 months after study drug discontinuation or have had a vasectomy.
    E.4Principal exclusion criteria
    1.Patient previously participated in any study with nabilone.
    2.Current use of cannabinoids or use of cannabinoids within 30 days prior to screening.
    3.Patient is currently participating in or has participated in another study of investigational products within 30 days prior to screening.
    4.Patient has any form of secondary or atypical parkinsonism (e.g., drug-induced, post stroke).
    5.Patient presents with motor complications which are, based on the investigator’s judgment, not adequately controlled (i.e. a score ≥2 on one of the items of the MDS-UPDRS Part IV at screening)
    6.Hoehn and Yahr stage > 3
    7.Evidence of disturbing (i.e. requiring treatment) impulse control disorder in the participant. Can be resolved through a structural interview during screening period.
    8.History of neurosurgical intervention for PD
    9.presence of symptomatic orthostatic hypotension at screening (MDS-UPDRS 1.12 > 2)
    10.Use of prohibited medication listed in 7.4.2
    11.Patients with laboratory values that are out-of-range at Screening or within 4 weeks prior to screening and haven´t been reviewed and documented as not clinically significant by the investigator. Lab Tests can be repeated for confirmation.
    12.Patients with known or newly diagnosed sinus tachycardia in ECG Evaluation at screening or within 4 weeks prior to screening.
    13.presence of an acute or chronic major psychiatric disorder (e.g., Major Depressive Disorder, psychosis) or symptom (e.g., hallucinations, agitation, paranoia) (MDS-UPDRS 1.2 and/or 1.3 > 2)
    14.Patients who had a recent suicidal attempt (active, interrupted, aborted) within the past five years or report suicidal ideation within the past 6 months.
    15.presence of dementia (MDS-UPDRS 1.1 > 2, MMSE of <24 at the Screening visit)
    16.clinically significant or unstable medical or surgical condition at Screening or Baseline visit that may preclude safety and the completion of the study participation (based on the investigator’s judgment).
    17.Patients with moderate or severe hepatic or renal impairment.
    18.Patient has a history of chronic alcohol or drug abuse within the last 2 years.
    19.women of child-bearing potential who do not practice an acceptable method of birth control (See: acceptable methods of birth control at 4.1.)
    20.Pregnant women or women planning to become pregnant during the course of the study and nursing women.
    21.Patients who are knowingly hypersensitive to any of the components of the IMP or excipients.
    22.Patient is legally incapacitated (for example: patient ist incapable of giving consent personally) or persons held in an institution by legal or official order
    23.Persons with any kind of dependency on the investigator or employed by the Sponsor or investigator
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Week 4/Termination Visit in the MDS-UPDRS Part I (non-motor Expriences of daily living; nmEDL)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy criterion will be measured as the change of the MDS-UPDRS Part I between baseline and week 4.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    The change in the other assessments listed above between baseline and week 4 will be the key secondary efficacy criteria, as well as the CGI-I at Termination Visit.

    Safety Endpoints:
    The safety and tolerability of nabilone will be evaluated in this study using the measures described in 2.1.3. between Baseline and Week 4.


    Exploratory Endpoint:
    The change of the reaction time, attention span, and concentrativeness between Screening and Termination Visit as measured by the Eye-tracking examination will be an exploratory endpoint.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The key secondary efficacy criteria will be measured as the change in the other assessments between baseline and week 4.
    The Eye-tracking Evaluation will be measured as the change between Screening and the Termination Visit.
    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 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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    enriched enrolment randomized withdrawal study
    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.8.5The 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
    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 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 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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state48
    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 end of the study treatment, alternative methods for the therapy of disturbing non-motor symptoms in PD can be prescribed to the patients, keeping in mind the patient´s tolerance. If the patient has shown benefit from the therapy with nabilone, a cannabinoid therapy could be prescribed on behalf of the investigator´s decision.
    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 Decision2017-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-15
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