Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-004439-36
    Sponsor's Protocol Code Number:ACP-103-047
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-06-25
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2017-004439-36
    A.3Full title of the trial
    A 52-Week Open-Label Extension Study of Pimavanserin in Adult and Elderly Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
    52týdenní nezaslepené prodloužení studie pimavanserinu u dospělých a starších subjektů s neuropsychiatrickými příznaky souvisejícími s neurodegenerativním onemocněním
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and tolerability of long-term pimavanserin treatment in subjects with neuropsychiatric symptoms related to neurodegenerative disease
    A.4.1Sponsor's protocol code numberACP-103-047
    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 Address12830 El Camino Real, Suite 400
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1858 320-8614
    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 10mg
    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 number10
    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.IMP: 2
    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 17mg
    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
    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 long-term pimavanserin treatment in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease
    E.2.2Secondary objectives of the trial
    To explore the safety and tolerability of long-term pimavanserin treatment in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease on the following:
    - suicidality
    - cognition
    - extrapyramidal symptoms

    To explore the benefit of long-term pimavanserin treatment in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease on:
    - clinical global impression of neuropsychiatric symptoms
    - quality of life
    - sleep
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject satisfied all entry criteria for the antecedent pimavanserin study
    2. The subject may benefit from longer term therapy with open-label pimavanserin treatment in the judgment of the Investigator
    3. Subject completed the antecedent study; or was participating in a pimavanserin study that the Sponsor ended early
    4. 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. Subjects with moderate or severe dementia, as evaluated by the Investigator, must live with a
    responsible adult who can provide direct supervision and monitoring of study medication administration. Subjects with mild dementia, as evaluated by the Investigator, must have close monitoring of study drug administration.
    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
    5. Subject can come to the clinic for study visits with a study partner/caregiver
    6. Subject is willing and able to provide informed consent. Consent for the present study must be obtained prior to the final procedures being performed at antecedent study’s EOT visit or ET visit (if the study was ended early by the Sponsor). 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
    7. 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 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:
    a. Condom, diaphragm, or cervical cap with spermicide
    b. Hormonal contraception, including oral, injectable, transdermal, or implantable methods
    c. Intrauterine device (IUD)
    E.4Principal exclusion criteria
    1. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to AEs,
    medical condition, or noncompliance with investigational product or study procedures in the antecedent study, or is judged to be a danger to self or others
    2. Is in hospice, is receiving end-of-life palliative care, or has become bedridden
    3. Has any of the following ECG results at the EOT/ET visit of the antecedent study:
    a. If the subject is not on citalopram, escitalopram, or venlafaxine:
    i. QTcF >450 ms, if QRS duration <120 ms
    ii. QTcF >470 ms, if QRS duration ≥120 ms
    b. If the subject is on citalopram, escitalopram, or venlafaxine:
    i. QTcF >425 ms, if QRS duration <120 ms
    ii. QTcF >450 ms, if QRS duration ≥120 ms
    4. Has a heart rate <50 or >100 beats per minute, and/or a blood pressure of >165 mmHg (systolic) or >95 mmHg (diastolic)
    5. Has a body mass index (BMI) <18.5 kg/m2 or known unintentional clinically significant weight loss (i.e., ≥7% of body weight) over past 6 months
    6. Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:
    a. jeopardize the safe participation of the subject in the study; OR
    b. would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
    7. Is suicidal as defined below at Visit 1 (Baseline) of the ACP-103-047 study:
    a. If the subject was assessed in the antecedent study using the Columbia-Suicide Severity Rating Scale
    (C-SSRS), he or she must not be actively suicidal at Visit 1 (Baseline) (including an answer of “yes” to
    C-SSRS questions 4 or 5) and must not have attempted suicide (using the “Since Last Visit”
    version) prior to Visit 1 (Baseline) of the present study; OR
    b. If the subject is not able to reliably complete the C-SSRS in the Investigator’s judgment or if the
    Global Clinician Assessment of Suicidality (GCAS) scale was used in the antecedent study, the subject
    must not be suicidal as assessed by the GCAS score (i.e., a score of 3 or 4) based on Investigator’s
    assessment of behavior since-last-visit at Visit 1 (Baseline); OR
    c. The subject is actively suicidal in the Investigator’s judgment
    8. Has developed a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator,
    would increase the risk associated with taking study medication or significantly interfere with the conduct or
    interpretation of the study
    9. Requires treatment with a medication or other substance that is prohibited by the protocol
    10. Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
    11. Is an employee of ACADIA, or has a family member who is an employee of ACADIA
    E.5 End points
    E.5.1Primary end point(s)
    Treatment emergent adverse events (TEAEs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After final Database lock
    E.5.2Secondary end point(s)
    Safety and tolerability are described by:
    - Columbia-Suicide Severity Rating Scale (C-SSRS) score or Global Clinician Assessment of Suicidality (GCAS) scale (if the subject is not able to complete the C-SSRS in the Investigator’s judgment)
    - Mini-Mental State Examination (MMSE)
    - Extrapyramidal Symptom Rating Scale A (ESRS-A)
    E.5.2.1Timepoint(s) of evaluation of this end point
    After final Database lock
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Colombia
    Georgia
    Mexico
    Serbia
    South Africa
    Bulgaria
    Czechia
    Poland
    Romania
    Russian Federation
    Ukraine
    United States
    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
    The end of the clinical study will be when the last subject completes the last scheduled assessment (i.e., safety follow up).
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 675
    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
    If a subject is deemed not competent to give consent, the subject’s legally acceptable representative or caregiver, if local regulations allow, must provide written informed consent and the subject must provide written (if capable) informed assent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 288
    F.4.2.2In the whole clinical trial 750
    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 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 Decision2018-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-05-05
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 01:46:02 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA