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    Summary
    EudraCT Number:2016-004629-18
    Sponsor's Protocol Code Number:helmich-veni-2019
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-01-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-004629-18
    A.3Full title of the trial
    The noradrenergic basis of Parkinson’s tremor: a systems-level fMRI approach
    De noradrenerge basis van Parkinson tremor: een fMRI studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The influence of stress on Parkinson's tremor
    De invloed van het stress systeem op Parkinson tremor
    A.3.2Name or abbreviated title of the trial where available
    Noradrenergic basis of Parkinson tremor
    Noradrenerge basis van Parkinson tremor
    A.4.1Sponsor's protocol code numberhelmich-veni-2019
    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 SponsorRadboud University Nijmegen
    B.1.3.4CountryNetherlands
    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 supportNetherlands Organization for Scientific Research
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud, Donders Institute
    B.5.2Functional name of contact pointAdministration
    B.5.3 Address:
    B.5.3.1Street AddressKapittelweg 29
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 EN
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031243610750
    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 Yes
    D.2.1.1.1Trade name Propranolol
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namePropranolol HCl CF 40 mg tablet
    D.3.2Product code RVG 55618
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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) 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
    Tremor in Parkinson's disease
    Tremor bij de ziekte van Parkinson
    E.1.1.1Medical condition in easily understood language
    Tremor in Parkinson's disease
    Tremor bij de ziekte van Parkinson
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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 describe the critical role of the locus coeruleus-noradrenaline system in the pathophysiology of Parkinson’s tremor.
    Om de rol van het locus coeruleus-noradrenerge systeem in de pathofysiologie van de ziekte van Parkinson te beschrijven.
    E.2.2Secondary objectives of the trial
    - To test the ability of propranolol to inhibit stress­-induced resting tremor.
    - To identify patient-specific noradrenergic markers (functional and structural) that predict how sensitive his/her tremor is to acute psychological stress and a targeted pharmacological intervention (propranolol).
    - Om te testen in hoeverre propranolol stress-geinduceerde Parkinson tremor vermindert.
    - Om patient-specifieke noradrenerge markers (functioneel en structureel) te identificeren die voorspellen hoe gevoelig zijn/haar tremor is voor acute psychische stress en een gerichte farmacologische interventie (propranolol).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - idiopathic Parkinson’s disease according to UK Brain Bank criteria
    - tremor-­dominant phenotype (defined as a resting tremor score of >= 2 UPDRS points for at least one arm)
    - idiopathische ziekte van Parkinson volgens de UK Brain Bank criteria
    - tremor-dominant fenotype (gedefinieerd als een rust tremor score van >= 2 UPDRS punten voor ten minste 1 arm
    E.4Principal exclusion criteria
    - use of beta-blockers
    - neuropsychiatric co-morbidity
    - contraindications for MRI scanning (e.g. pacemaker, implanted metal parts, deep brain stimulation, claustrophobia)
    - Cardiac arrhythmias (in patient history or visible on ECG)
    - contraindications for beta blockers (e.g. bradycardia, peripheral circulation disturbances, asthma or obstructive lung disease, hypotension)
    - Use of medication that may interact with propranolol, e.g. other bèta-blockers, calcium antagonists, digoxine, cimetidine, hydralazine, fluvoxamine, rifampicine, barbiturates, amiodaron, flecainide, kinidine, propafenon, disopyramide, chlorpromazine, and clonidine
    - Use of medication that inhibits relevant CYP enzymes that are involved in metabolizing propranolol (CYP2D6, CYP1A2, and CYP2C19): fluoxetine, paroxetine, sertraline, duloxetine, terbinafine, cinacalcet, bupropion, and ciprofloxacine
    - Severe head tremor or dyskinesias
    - Cognitive impairment (MMSE < 26)
    - gebruik van beta blokkers
    - neuropsychiatrische co-morbiditeit
    - contraindicaties voor MRI onderzoek (bijvoorbeeld pacemaker, geimplanteerd metaal, DBS electrodes, claustrofobie)
    - contraindicaties voor beta-­blokkers (bijvoorbeeld 1e graad AV block, bradycardie, gestoorde perifere circulatie, astma of obstructieve longziekte, hypotensie)
    - Medicatie die kan interacteren met propranolol, andere bèta-blokkers, calcium antagonisten, digoxine, cimetidine, hydralazine, fluvoxamine, rifampicine, barbituraten, amiodaron, flecainide, kinidine, propafenon, disopyramide, chlorpromazine, clonidine.
    - Medicatie die relevant CYP enzymen remt die betrokken zijn in metabolizeren van propranolol (CYP2D6, CYP1A2, and CYP2C19): fluoxetine, paroxetine, sertraline, duloxetine, terbinafine, cinacalcet, bupropion, and ciprofloxacine
    - Ernstige hoofdtremor of dyskinesieen
    - Cognitieve stoornissen (MMSE < 26)
    E.5 End points
    E.5.1Primary end point(s)
    Change in tremor-related cerebral activity and connectivity (fMRI BOLD signal)
    Verandering in tremor-gerelateerde activiteit en connectiviteit (fMRI BOLD signaal)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study (01-02-2022)
    Aan het einde van de studie (01-02-2022)
    E.5.2Secondary end point(s)
    - Change in clinical tremor score (UPDRS)
    - Change in autonomous stress markers (salivary cortisol, heart rate, blood pressure, pupil diameter)
    - Verandering in klinische tremor score (UPDRS)
    - Verandering in autonome stress markers (cortisol in speeksel, hart frequentie, bloeddruk, pupil diameter)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study (01-02-2022)
    Aan het einde van de studie (01-02-2022)
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Pathophysiology: the role of the noradrenergic system in Parkinson's tremor
    Pathofysiologie: de rol van het noradrenerge systeem in Parkinson tremor
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    niet-medicinaal product (cellulose in water)
    non-medicinal product (cellulose in water)
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    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)
    None
    Geen
    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 Decision2017-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-09-06
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