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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-003536-36
    Sponsor's Protocol Code Number:ACP-103-046
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-05-25
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2017-003536-36
    A.3Full title of the trial
    A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled, Safety Study of Pimavanserin Therapy in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
    Un studiu de fază 3b, multicentric, randomizat, în regim dublu-orb, controlat cu placebo, de evaluare a siguranței tratamentului cu Pimavanserin la subiecții adulți și vârstnici cu simptome neuropsihiatrice asociate bolii neurodegenerative
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety of Pimavanserin Therapy in subjects With Neuropsychiatric Symptoms related to neurodegenerative disease.
    A.4.1Sponsor's protocol code numberACP-103-046
    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 SponsorACADIA Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    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 organisationACADIA Pharmaceuticals Inc.
    B.5.2Functional name of contact pointRegulatory Affairs (Teresa Brandt)
    B.5.3 Address:
    B.5.3.1Street Address3611 Valley Centre Drive, Suite 300
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1858261-2934
    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 namePimavanserin
    D.3.2Product code ACP-103
    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.3.9.1CAS number 706782-28-7
    D.3.9.2Current sponsor codepimavanserin ACP-103
    D.3.9.3Other descriptive namePIMAVANSERIN TARTRATE
    D.3.9.4EV Substance CodeSUB128275
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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
    Neuropsychiatric Symptoms Related to Neurodegenerative Disease
    E.1.1.1Medical condition in easily understood language
    Neuropsychiatric symptoms including ones related to behavior such as hallucinations delusions, irritability, apathy (lack of emotion/interest) and agitation (feeling of restlessness and being tense)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    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
    To assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease, as described by:
    o extrapyramidal symptoms
    o cognition
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Is a male or female ≥60 years of age
    2. Can understand the nature of the trial and protocol requirements and provide written informed consent
    If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met
    a. The subject’s legally acceptable representative (LAR) (or study partner/caregiver, if local regulations allow) must provide written informed consent
    b. The subject must provide written (if capable) informed assent
    3. Subject requires some or complete assistance with one or more of the following
    a. Instrumental activities of daily living (communication, transportation, meal preparation, shopping, housework, managing medications, managing personal finances) OR
    b. Basic activities of daily living (personal hygiene, dressing, eating, maintaining continence or transferring)
    4. Meets clinical criteria for at least one of the following disorders, with or without cerebrovascular disease (CVD)
    a. Parkinson’s disease with or without dementia as defined by the Movement Disorder Society’s Task Force
    b. Dementia with Lewy bodies (DLB)
    c. All-cause dementia, possible or probable Alzheimer’s disease (AD)
    d. Frontotemporal degeneration spectrum disorders, including possible or probable: i. Behavioral variant frontotemporal dementia ii. Progressive supranuclear palsy iii. Corticobasal degeneration
    e. Vascular dementia, including post-stroke dementia, multi-infarct dementia and/or subcortical ischemic vascular dementia (SIVD)
    6. Has neuropsychiatric symptoms severe enough to warrant treatment with an antipsychotic agent.
    7. Has a CGI-S score of ≥4 when assessing neuropsychiatric symptoms at Visit 1 and Visit 2
    9. Has a designated study partner/caregiver who meets the following requirements
    a. In the Investigator’s opinion, is in contact with the subject frequently enough to accurately report on the subject’s symptoms and whether or not the subject is taking the study drug
    b. In the Investigator’s opinion, is considered reliable in providing support to the subject to help ensure compliance with study treatment, study visits, and protocol procedures
    c. Is fluent in the local language in which study assessments will be administered
    d. Agrees to participate in study assessments, has the capacity to provide informed consent, and provides written consent to participate in the study
    13. If the subject is taking an antipsychotic medication at the time of screening, the antipsychotic medication must be discontinued 2 weeks or 5 half-lives (whichever is longer) prior to Visit 2. Investigators should not withdraw a subject’s prohibited medication for the purpose of enrolling them into the study unless discontinuation of the medication is deemed to be clinically appropriate (e.g. symptoms are not well-controlled or the subject cannot tolerate the current medication)
    14. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception or be abstinent for at least 1 month prior to Visit 2 during the study, and 1 month following completion of the study
    Abstinence as a method of contraception is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. This option is usually made for a specific moral, religious, legal, or health reason. If heterosexual intercourse does occur, an acceptable method of birth control is required.
    Acceptable methods of birth control include the following
    Condom, diaphragm, or cervical cap with spermicide
    • Hormonal contraception, including oral, injectable, transdermal, or implantable methods
    • Intrauterine device (IUD)

    Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
    E.4Principal exclusion criteria
    1. Is in hospice, is receiving end-of-life palliative care, or is bedridden
    2. Has neuropsychiatric symptoms that are primarily attributable to current delirium or substance abuse i.e., neuropsychiatric symptoms not related to neurodegenerative disease
    3. Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
    4. Has a history of epilepsy
    5. Has atrial fibrillation unless adequately anticoagulated
    6. Has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident within the last 6 months prior to V1
    7. Has any of the following
    a greater than New York Heart Association (NYHA) Class 2 congestive heart failure
    b Grade 2 or greater angina pectoris (by Canadian CV Society Angina Grading Scale) c. sustained ventricular tachycardia
    d ventricular fibrillation e. torsades de pointes
    f syncope due to an arrhythmia g. an implantable cardiac defibrillator
    8 Has a history of human immunodeficiency virus (HIV) or hepatitis C infection
    9 Has a history of neuroleptic malignant syndrome or serotonin syndrome
    10 Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
    13. Has a clinically significant CNS abnormality that is most likely contributing to the dementia or findings on MRI or CT including:
    a. intracranial mass lesion (including but not limited to meningioma [>1 cm3 with evidence of peritumoral edema] or glioma)
    b. vascular malformation c. evidence of >4 hemosiderin deposits (definite microhemorrhage or superficial siderosis)
    14. Has clinically significant neuroimaging or laboratory abnormalities during Screening that in the judgment of the Investigator would jeopardize the safe participation of the subject in the study. In consultation with the Medical Monitor, these subjects may be rescreened after appropriate treatment of their medical condition
    16. Requires treatment with a medication or other substance that is prohibited by the protocol
    18. The urine drug screen result at Visit 1 indicates the presence of amphetamine/methamphetamine, barbiturates, cocaine, or phencyclidine (PCP) Subjects who test positive for amphetamines may be retested during Screening if they agree to abstain from the medication for the length of their participation in he study and if abstinence from medication usage is achieved at least 7 days prior to Visit 2
    19. Is suicidal at Screening or Baseline as defined below
    a. If the subject can complete the Columbia Suicide Severity Rating Scale (C-SSRS), he or she must not be actively suicidal at Visit 1 or Visit 2 (including, an answer of “yes” to C-SSRS questions 4 or 5 [current or over the last 6 months]) and must not have attempted suicide in the 2 years prior to Visit 1 OR
    b. If the subject is not able to reliably complete the C-SSRS in the Investigator’s judgment, the subject must not be suicidal as assessed by the Global Clinician Assessment of Suicidality (GCAS) score (i.e. a score of 3 or 4) based on Investigator’s assessment of behavior within the 3 months prior to Visit 1 or since-last-visit at Visit 2 OR
    c. The subject is actively suicidal in the Investigator’s judgment
    20. Has participated in or is participating in a clinical trial of any investigational drug, device, or intervention, within 30 days or 5 half-lives, whichever is longer, of Visit 2
    21. Has previously been enrolled in any prior clinical study with pimavanserin or is currently taking pimavanserin.
    22. Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
    23. Is an employee or is a family member of an employee of ACADIA Pharmaceuticals Inc.
    24. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason, including if the subject is judged to be a danger to self or others

    Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
    E.5 End points
    E.5.1Primary end point(s)
    The primary measure for this study is treatment-emergent adverse events (TEAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after last dose of study drug given at the Week 8 visit
    E.5.2Secondary end point(s)
    The secondary endpoints for this study are as follows:
    •Change from Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS A)
    •Change from Baseline to Week 8 in Mini-Mental State Examination (MMSE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8
    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 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Colombia
    Mexico
    South Africa
    United States
    Poland
    Bulgaria
    Romania
    Czechia
    Georgia
    Hungary
    Russian Federation
    Serbia
    Ukraine
    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
    LSLV
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 270
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In the case of reduced decision-making capacity, legally acceptable representative or caregiver consistent with national law, able to read, understand and provide written informed consent in the designated language of study site will provide consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 300
    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)
    Patients who complete the 8 week double-blind treatment period may have the opportunity to enroll in the 1 year open label extension study ACP-103-047.

    Patients who do not wish to participate in the open label extension study will return to the appropriate standard of care for their condition as determined by their treating physician
    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 Decision2019-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-24
    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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