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    Summary
    EudraCT Number:2016-001229-15
    Sponsor's Protocol Code Number:6398
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-19
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-001229-15
    A.3Full title of the trial
    Study of pimavanserin efficacy for the treatment of impulse control
    disorders in Parkinson's disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of pimavanserin efficacy for the treatment of impulse control
    disorders in Parkinson's disease
    A.3.2Name or abbreviated title of the trial where available
    PIMPARK
    A.4.1Sponsor's protocol code number6398
    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 SponsorHôpitaux Universitaires de Strasbourg
    B.1.3.4CountryFrance
    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 supportFrench Ministry of Health
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportAcadia Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpitaux Universitaires de Strasbourg
    B.5.2Functional name of contact pointEric DEMONSANT
    B.5.3 Address:
    B.5.3.1Street Address1, place de l'hôpital
    B.5.3.2Town/ cityStrasbourg
    B.5.3.4CountryFrance
    B.5.6E-maildpidrci@chru-strasbourg.fr
    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 NUPLAZID
    D.2.1.1.2Name of the Marketing Authorisation holderAcadia Pharmaceuticals Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namePimavanserin
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNPIMAVANSERIN
    D.3.9.4EV Substance CodeSUB183869
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number17
    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 placeboFilm-coated tablet
    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
    Impulse control disorders (ICD) in Parkinson's disease
    E.1.1.1Medical condition in easily understood language
    Impulse control disorders (ICD) in Parkinson's disease
    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
    The primary objective of this study is to evaluate the efficacy of
    pimavanserin (a selective serotonin 5-HT2A inverse agonist), versus
    placebo, after 8 weeks of treatment at stable dosage, on the severity of
    ICD in PD.
    E.2.2Secondary objectives of the trial
    The key secondary objectives of this study are:
    1. To evaluate the tolerance of pimavanserin after 4 weeks and 8 weeks
    at stable dosage and after 8 weeks free of treatment, versus placebo,
    regarding both non-motor signs (hyper- and hypodopaminergic
    behavior, sleep, depression) and motor signs of PD.
    2. To evaluate the efficacy of pimavanserin after 4 weeks at stable
    dosage, versus placebo, on the severity of ICD in PD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with PD according to the UKPDSBB criteria for at least 1 year
    before randomization
    2. Patient, man or woman, aged from 35 to 75 years old
    3. Patient with moderately severe ICD defined as:
    • a combined ICD total score (defined as the sum of the 4 ICD subscores
    (pathological gambling + buying + hypersexuality + eating)) 
    10 or,
    • at least one of the 4 ICD sub-scores in the following range:
    a. "pathological gambling" sub-score from 6 to 12 (included),
    b. "buying" sub-score from 8 to 12 (included),
    c. "hypersexuality" sub-score from 8 to 12 (included),
    d. "eating" sub-score from 7 to 12 (included) (Weintraub et al., 2012).
    The use of "lower" margins will guarantee that the patient experiences
    behavioral disturbances severe enough to justify pimavanserin
    treatment. On the other hand, the use of "upper" margins will guarantee
    that the patients included in the trial will not suffer from ICD severe
    enough to question ethically the use of placebo during the 8 weeks of
    the treatment
    4. ICD onset after PD onset and after initiation of dopaminergic drugs
    5. Patient treated by dopaminergic drugs for at least 3 months before
    randomization
    6. Patient treated with a stable regimen of levodopa, dopamine
    agonists, COMT and MAOB inhibitors, amantadine, anticholinergic,
    antidepressant and benzodiazepine for at least 1 month before the
    randomization and be willing to remain on the same doses throughout
    the course of their participation in the trial (Papay et al., 2014)
    7. Patient with health insurance
    8. Patient/ guardian / curator who sign the written informed consent
    9. For women of childbearing potential, use of an effective
    contraception method* for at least 1 month prior to randomization until
    8 weeks after the last dose of study drug administration. Women who do
    not have an effective contraception* must : have had her last natural
    menstruation ≥24 months prior to the selection visit, or have been
    surgically sterilized prior to the selection visit, or have had a
    hysterectomy prior to the selection visit.
    E.4Principal exclusion criteria
    1. Patient suffering from another parkinsonian syndrome (multiple
    system atrophy, progressive supranuclear palsy, Lewy body dementia,
    corticobasal degeneration)
    2. Patient who have a known hypersensitivity to the study treatment,
    based on known allergies to drugs of the same class
    3. Stroke, uncontrolled serious medical illness, myocardial infarction,
    congestive heart failure, cardiac function disorders, within 6 months
    before randomization
    4. Patient with history of long QT syndrome
    5. Patient with long QTcB detected with ECG at inclusion visit (> 450
    ms)
    6. Patient treated with antipsychotic drugs during the last three months
    before randomization
    7. Patient treated with concomitant medication leading to torsade de
    pointes (TdP) (please refer to medications list with known risks of TdP
    on appendix XVII.5.10 and check website
    https://crediblemeds.org/index.php/tools/ for the most up-to-date
    information)
    8. Patient with hydro-electrolytics troubles, particularly hypokaliemia
    or hypocalcemia not corrected, at inclusion visit
    9. Patient treated with a strong inhibitor of CYP3A4: azole antifungals,
    protease inhibitors, macrolids without discontinuation ≥ 5 half-lives
    before randomization
    10. Patient treated with medicinal plants interacting with CYP3A4
    (Echinacea (E.pupurea, E.angustifolia and E.pallida), Piperina, Artemisia,
    St. John's Wort et Ginkgo
    11. Patient with Montreal Cognitive Assessment (MoCA) (Nasreddine et
    al., 2005) score < 20 (to exclude patients likely with dementia) at
    inclusion visit (Papay et al., 2014).
    12. Patient suffering from severe depression or marked suicidal
    thoughts (score > 3 on the suicidal thoughts item of the MADRS) at
    inclusion visit (Papay et al., 2014)
    13. History of DBS within the past year before randomization
    14. Patient suffering from a cancer
    15. Patient suffering from severe renal impairment define as CrCL <30
    mL/min, Cockcroft-Gault at inclusion visit
    16. Clinically significant hepatic impairment
    17. Current participation in another research involving human beings of category 1 or 2
    18. Patient with language barriers precluding adequate understanding
    or co-operation or who, in the opinion of the investigator, should not
    participate in the trial
    19. Treatment with an investigational treatment within 30 days prior to
    randomization
    20. Woman pregnant, nursing or of childbearing potential age without
    effective contraception methods or intends to become pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the change in ICD severity,
    evaluated using the total ICD score of the Impulse-Compulsive Disorder
    in Parkinson's disease rating scale (QUIP-RS), between D0 (baseline,
    Visit 1) and W8 (after 8 weeks of treatment at stable dosage, Visit 4).
    E.5.1.1Timepoint(s) of evaluation of this end point
    D0, Week 8
    E.5.2Secondary end point(s)
    The secondary endpoints of this study are:
    1. The change from D0 (baseline, Visit 1) to W4 (after 4 weeks of
    treatment with pimavanserin or placebo, Visit 3) as well as from D0 to
    W8 (after 8 weeks of treatment with pimavanserin or placebo, Visit 4) in
    scores of various validated questionnaires evaluating motor and nonmotor
    symptoms of PD (SCOPA-DS, SCOPA-NS, MDS-UPDRS, MADRS,
    Ardouin's scale).
    2. The change from D0 (baseline, Visit 1) to W4 (after 4 weeks of
    treatment with pimavanserin or placebo, Visit 3), from D0 to W8 (after 8
    weeks of treatment with pimavanserin or placebo, Visit 4) as well as
    from D0 to W16 (end of study, last phone call) in the rate of CGIS scale.
    3. The change in the ICD total score of the QUIP-RS from D0 (baseline,
    Visit 1) to W4 (after 4 weeks of treatment with pimavanserin or placebo,
    Visit 3).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 : D0, Week 4, Week 8
    2: D0, Week 4, Week 8, Week 16
    3: D0, Week 4
    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 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned15
    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 Yes
    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 years
    E.8.9.1In the Member State concerned months28
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Subjects under guardianchip
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NS PARK
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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