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    Summary
    EudraCT Number:2017-004006-18
    Sponsor's Protocol Code Number:ParkinsonDPI-3
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-004006-18
    A.3Full title of the trial
    Therapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease
    Therapeutische effecten van een inhaleerbare levodopa droogpoeder formulering op het herstel van off-periodes bij patiënten met de ziekte van Parkinson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's disease
    Het effect van inhaleerbare levodopa op het herstel van off-periodes bij patiënten met de ziekte van Parkinson
    A.3.2Name or abbreviated title of the trial where available
    Effectiveness of inhaled levodopa in Parkinson's disease
    Effectiviteit van inhaleerbare levodopa bij de ziekte van Parkinson
    A.4.1Sponsor's protocol code numberParkinsonDPI-3
    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 SponsorPharmaceutical Technology and Biopharmacy, University of Groningen
    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 supportParkinson Vereniging
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportMartini Ziekenhuis Groningen
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportUniversity of Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaceutical Technology and Biopharmacy, University of Groningen
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressAntonius Deusinglaan 1 - XB21
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 AV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031503633254
    B.5.5Fax number0031503632500
    B.5.6E-maila.j.lexmond@rug.nl
    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 nameLevodopa powder for inhalation
    D.3.2Product code Levodopa Cyclops
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlevodopa
    D.3.9.1CAS number 59-92-7
    D.3.9.2Current sponsor codelevodopa
    D.3.9.3Other descriptive nameLEVODOPA
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number60 to 90
    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 Yes
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Madopar 125 mg, orodispersible tablet
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Nederland B.V.
    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.3.4Pharmaceutical form Orodispersible 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
    Parkinson's disease is a progressive neurodegenerative disorder characterized by a lack of dopamine production due to the loss of dopamine producing cells in the substantia nigra. This lack of dopamine causes disruption of motor circuits in the brain resulting in motor function impairments like tremor, rigidity and bradykinesia.
    De ziekte van Parkinson is een progressieve neurodegeneratieve ziekte die wordt gekenmerkt door een tekortschietende dopamineproductie als gevolg van het verlies van dopamineproducerende cellen in de substantia nigra. Een tekort aan dopamine leidt tot de verstoring van motorische verbindingen in de hersenen. Dit resulteert in motorische functiestoornissen, zoals tremor, rigiditeit en bewegingstraagheid.
    E.1.1.1Medical condition in easily understood language
    Parkinson's disease is a movement disorder, caused by a lack of the neurotransmitter dopamine in the brain. The main symptoms are shaking, stiffness and slowness of movement.
    Bij de ziekte van Parkinson is er een tekort aan het stofje dopamine in de hersenen, wat zorgt voor verstoringen van de manier van bewegen. De klachten zijn trillen, stijfheid en traag bewegen.
    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 LLT
    E.1.2Classification code 10013113
    E.1.2Term Disease Parkinson's
    E.1.2System Organ Class 100000004852
    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 duration until maximum effect is reached of inhaled levodopa on the improvement of motor function of Parkinson's disease patients during an off period.
    De bepaling van de duur tot het maximale effect is bereikt van inhaleerbare levodopa op de verbetering van de motorfunctie van Parkinson patiënten die zich in een off periode bevinden.
    E.2.2Secondary objectives of the trial
    To determine to what extent the motor function of Parkinson's disease patients improves after inhalation of levodopa in comparison to oral levodopa.
    De bepaling in welke mate de motorfunctie van Parkinson patiënten verbetert na inhalatie van levodopa in vergelijking met oraal toegediende levodopa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosed with Parkinson’s disease;
    - At least 18 years of age;
    - Predictable off periods;
    - Recognisable off periods for themselves and others;
    - Sufficiently large (measurable) difference between on and off state (10 points on UPDRS III scale);
    - At least 2 years of levodopa use;
    - Able to perform spirometry;
    - Signed informed consent.
    - Gediagnosticeerd met de ziekte van Parkinson;
    - 18 jaar of ouder;
    - Voorspelbare off-periodes;
    - Herkenbare off-periodes voor de patiënt zelf en anderen;
    - Voldoende groot (meetbaar) verschil tussen 'on' en 'off' (10 punten op de UPDRS III schaal);
    - Tenminste 2 jaar levodopa gebruik;
    - In staat spirometrie uit te voeren;
    - Getekende toestemmingsverklaring.
    E.4Principal exclusion criteria
    - Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent;
    - Current treatment with apomorphine or duodopa by pump;
    - Severe off periods during the night;
    - Current or past experience with depression/depressed mood;
    - Known symptomatic orthostatic hypotension;
    - Active pulmonary disease;
    - Pregnancy or breast-feeding.
    - Cognitieve dysfunctie, waardoor geen goed begrip van instructies en/of toestemmingsverklaring mogelijk is;
    - Huidige behandeling met apomorfine of duodopa per pomp;
    - Ernstige nachtelijke off-periodes;
    - Huidige of eerdere ervaring met depressie/depressieve klachten;
    - Bekende symptomatische orthostatische hypotensie;
    - Actieve longaandoening;
    - Zwanger of borstvoedend.
    E.5 End points
    E.5.1Primary end point(s)
    The UPDRS III score will be assessed pre-dose and on set time points up to 90 min post-dose as measure for motor function. The primary outcome is the time until the maximum effect on motor function (largest change in UPDRS III score) is found.
    De UPDRS III score wordt afgenomen voorafgaand aan toediening van de IMP en op gezette tijden tot 90 minuten na toediening als maat voor motorfunctie. De primaire uitkomstmaat is de tijd tot het maximale effect op de motorfunctie (grootste verandering in UPDRS III score) wordt gemeten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    On t = 10, 20, 30, 45, 60, 75 and 90 min post-dose
    Op t = 10, 20, 30, 45, 60, 75 en 90 min na toediening
    E.5.2Secondary end point(s)
    The secondary outcome is the maximum change in UPDRS III score compared to baseline as measure for the extent of the improvement in motor function.
    De secondaire uitkomstmaat is de maximale verandering in UPDRS III score ten opzichte van de uitgangswaarde als maat voor de mate van verbetering in motorfunctie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    On t = 10, 20, 30, 45, 60, 75 and 90 min post-dose
    Op t = 10, 20, 30, 45, 60, 75 en 90 min na toediening
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    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
    Laatste bezoek laatste patiënt
    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 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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state8
    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 Decision2017-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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