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    Summary
    EudraCT Number:2017-004253-16
    Sponsor's Protocol Code Number:NMSNab2study
    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:2018-02-27
    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 number2017-004253-16
    A.3Full title of the trial
    Nabilone for non-motor symptoms in Parkinson’s disease: An open-label study to evaluate long-term safety and efficacy
    Nabilon für nicht-motorische Symptome bei der Parkinsonkrankheit: eine offene Studie zur Evalierung von Langzeit-Sicherheit und Wirksamkeit
    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 dirsorders, cognitive dysfunction, hallucinations, autonomic dysfunction,...)
    A.4.1Sponsor's protocol code numberNMSNab2study
    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 code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number+4351250425810
    B.5.5Fax number+4351250425819
    B.5.6E-mailmarina.peball@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, hard
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subject 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 objective of this study is to evaluate long-term safety and tolerability of nabilone in PD patients.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the effects of long-term, open-label dosing with nabilone on different symptoms of PD and quality of life in patients with PD.


    The exploratory objective of this study will be an Eye-tracking evaluation in PD patients taking nabilone at Visit V 2 to examine the change of the reaction time, attention span, and concentrativeness.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In order to be eligible for the study, patients must have completed the double-blind phase of the NMS-Nab trial as responders within the last 2 months.
    2. For patients that completed NMS-Nab Study over 2 months prior to the Screening Visit, and meet all other inclusion criteria, eligibility should be discussed on a case-by-case basis.
    3. Only patients without a drug-related SAE or moderate or severe AE during the NMS-Nab Study can be included in the study
    4. Patients must be able and willing to provide written informed consent prior to any study related procedure being performed. Patients with a legal guardian should be consented according to local requirements.
    5. Patients must be willing and able to take oral medication and able to comply with the study specific procedures.
    6. The patient is in good health as determined by medical examination.

    The inclusion criteria of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal trial were as follows:
    1. age ≥30 years
    2. diagnosis of PD (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. Signed a current IRB-approved informed consent form
    7. Acceptable method of contraception
    E.4Principal exclusion criteria
    1. Patients that experienced a drug-related SAE or had a moderate or severe AE during the NMS-Nab Study will be excluded in the study.

    The exclusion criteria of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal trial were as follows:
    1. Previous participation in any study with nabilone
    2. current use of cannabinoids or use within 30 days prior to screening
    3. current or recent (within 30 days prior to screening) participation in another study with an investigational medicinal product
    4. atypical or secondary parkinsonism
    5. presence of motor complications if, 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 ON > 3
    7. Evidence of disturbing impulse control disorder
    8. History of neurosurgical intervention for PD
    9. Presence of clinically significant symptomatic orthostatic hypotension at screening (MDS-UPDRS 1.12 > 2)
    10. Use of prohibited medication listed in 7.4.2
    11. Laboratory values clinically significant out-of-range at screening or within 4 weeks prior to screening
    12. Known or 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. recent suicidal attempt within the past five years or suicidal ideation within the past 6 months
    15. presence of dementia (MDS-UPDRS 1.1 > 2, MMSE of < 24 at screening)
    16. clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation (based on the investigator’s judgment).
    17. moderate or severe hepatic or renal impairment.
    18. 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 [*Acceptable methods of birth control for women and men in this study are: surgical sterilization (e.g. tubal ligation for females), intrauterine devices that release hormones (hormone spiral), oral hormonal contraceptive, contraceptive patch, dermal hormonal contraception, vaginal hormonal contraception (NuvaRing®), implants that release progesterone (Implanon®), long-acting injectable contraceptive, partner’s vasectomy, a double-protection method, postmenopausal (> 2 year absence of vaginal bleeding).]
    20. Pregnant women, or women planning to become pregnant during the course of the study, or nursing women.
    21. Known hypersensitivity to any components of the IMP or excipients
    22. Patient is legally incapacitated 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)
    Primary Safety and tolerability endpoints:
    • Safety and tolerability will be evaluated with reference to the following:Number of subjects (%) who discontinue the study
    • Number of subjects (%) who discontinue the study due to AE
    • Adverse Events (AE)
    • Physical and neurological examination findings
    • Vital signs assessments
    • Subjects compliance, prior and concomitant medication use
    • Hallucination item (1.2) of Movement Disorders Society – Unified Parkinson´s Disease Rating Scale (MDS-UPDRS)
    • Orthostatic hypotension (OH) item (1.12) of Movement Disorders Society – Unified Parkinson´s Disease Rating Scale (MDS-UPDRS)
    • Day-time sleepiness item (1.8) of Movement Disorders Society – Unified Parkinson´s Disease Rating Scale (MDS-UPDRS) Suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary safety analysis will be performed with the safety data set including all patients with the intake of at least one study drug and performing at least V 1. A safety analysis will be performed on all events and tolerability issues, as well as the hallucination item, orthostatic hypotension item, the day-time sleepiness item of Part I of MDS-UPDRS, and C-SSRS occurring through the overall course of the study.
    E.5.2Secondary end point(s)
    Secondary Efficacy endpoints:
    Long-term efficacy evaluations are the secondary objective of this study. Efficacy endpoints include changes from V 1 to the termination visit (V 4) in the following assessments:
    • Total and different parts of MDS-UPDRS
    • Different domains of MDS-UPDRS Part I
    • NMSS
    • HAD-S
    • PDQ-8
    • ESS
    • FSS
    • KPPS
    • QUIP-RS
    • CGI-I

    The change of MMSE and MoCA score values between the Screening Visit of the NMS-Nab Study (before the first intake of nabilone medication) and the termination visit of this study will be assessed as secondary efficacy endpoints.


    Exploratory Endpoints
    The change of the reaction time, attention span, and concentrativeness between Screening and Termination Visit of the randomized placebo-controlled, double-blind, parallel-group, enriched enrolment randomized withdrawal study NMS-Nab and V 2 of this study as measured by the Eye-tracking examination will be an exploratory endpoint.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary efficacy criterion will be measured as the change of all assessments between V 1 and month 6, except for the MoCA and MMSE (will be compared between the Screening visit of the precursory NMS-Nab study and the Termination Visit of this study).



    The exploratory end point will be measured at V 2 of this study and compared to the Screening and Termination Visit of the precursory NMS-Nab Study.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 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 hast 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 Decision2018-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-31
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