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   43871   clinical trials with a EudraCT protocol, of which   7290   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:2018-003252-20
    Sponsor's Protocol Code Number:ACP-103-055
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-04-10
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-003252-20
    A.3Full title of the trial
    A 52-Week Open-Label Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety of pimavanserin in adult subjects with major depressive disorder
    A.4.1Sponsor's protocol code numberACP-103-055
    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 (Alida Barry)
    B.5.3 Address:
    B.5.3.1Street Address3611 Valley Centre Drive, Suite 300
    B.5.3.2Town/ citySan Diego, CA
    B.5.3.3Post code92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number001858261-2934
    B.5.6E-mailabarry@ACADIA-Pharm.com
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Major Depressive Disorder
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025454
    E.1.2Term Major depressive disorder, recurrent episode
    E.1.2System Organ Class 100000004873
    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 subjects with major depressive disorder and inadequate response to antidepressant treatment
    E.2.2Secondary objectives of the trial
    Exploratory Objectives
    •To explore the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment on the following:
    - suicidality
    - extrapyramidal symptoms
    - general health assessments


    •To explore the benefits of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment on the following:
    improvement of depression symptoms
    clinical global impression of severity of depressive symptoms
    general health assessments

    •To explore the benefits of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment on the following:
    improvement of depression symptoms
    clinical global impression of severity of depressive symptoms
    functional impairment
    sexual functioning


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Completed the antecedent study, Study ACP 103 054 or Study ACP-103-059
    2.May benefit from longer term therapy with open-label pimavanserin treatment in the judgment of the Investigator
    3.Is willing and able to provide informed consent. Consent for the present study must be obtained prior to the procedures being performed at the Week 6/EOT visit of Study ACP 103 054 or Study ACP-103-059
    4.Is capable of communicating with the site personnel, able to complete subject-reported outcome measures and can be reliably rated on assessment scales (in the opinion of the Investigator)
    5.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 TWO clinically acceptable methods of contraception during the study and 1 month following completion of the study.
    Acceptable methods of contraception include the following:
    a.A barrier method,condom, diaphragm, or cervical cap with spermicide
    b.Hormonal contraception, including oral, injectable, transdermal, or implantable methods
    c.Intrauterine device (IUD)
    Only one of the two clinically acceptable methods can be a hormonal method.
    E.4Principal exclusion criteria
    1.Is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to adverse events, medical condition, or noncompliance with investigational product or study procedures in Study ACP-103-054 or Study ACP-103-059, or is judged to be a danger to self or others
    2.Has any of the following electrocardiogram (ECG) results at Baseline (i.e.: Week 6/EOT visit of Study ACP-103-054 or Study ACP-103-059):
    a.If the subject is not on citalopram, escitalopram, or venlafaxine (immediate or extended release):
    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 (immediate or extended release):
    i.QTcF >425 ms, if QRS duration <120 ms
    ii.QTcF >450 ms, if QRS duration ≥120 ms
    3.Has a heart rate (as measured by peripheral pulse rate) <50 beats per minute at Baseline (i.e., the Week 6/EOT visit of Study ACP 103 054 or Study ACP-103-059) not explained by regular exercise or medication, in discussion with the Medical Monitor
    4.Has a body mass index (BMI) <18.5 kg/m2 or known unintentional clinically significant weight change (i.e., +/- ≥7% of body weight) in Study ACP 103 054 or Study ACP-103-059 as assessed by the Investigator
    5.Has clinically significant laboratory abnormalities 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
    6.Is suicidal as defined below at Visit 1 (Baseline) of the present study:
    a.An answer of “yes” to C SSRS questions 4 or 5 (current or over the last 6 months); OR
    b.Has attempted suicide within 1 year prior to Visit 1 (Baseline); OR
    c.Is actively suicidal in the Investigator’s judgment
    7.Has developed delirium or 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 or the Medical Monitor, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
    8.Requires treatment with a medication or other substance that is prohibited by the protocol
    9.Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
    10.Is an employee or is a family member of an employee of ACADIA Pharmaceuticals Inc.
    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)
    Exploratory Endpoints
    Safety and tolerability endpoints:
    •Columbia–Suicide Severity Rating Scale (C-SSRS)
    •Extrapyramidal Symptom Rating Scale–Abbreviated (ESRS-A) score
    •Vital signs
    •Body weight
    •Potentially clinically important laboratory values
    Efficacy endpoints:
    •Change from Baseline in Hamilton Depression Scale (17 items) (HAMD-17) total score
    •Treatment responder rates. Treatment response is defined as a reduction from Baseline in HAMD-17 total score of 50% or more.
    •Treatment remission rates. Treatmentremission is defined as a HAMD-17 total score ≤7.
    •Change from Baseline in Clinical Global Impression–Severity (CGI-S) score for depressive symptoms
    •Change from Baseline in Sheehan Disability Scale (SDS) score
    •Change from Baseline in the Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14) score
    •Change from Baseline in Karolinska Sleepiness Scale (KSS) score
    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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Bulgaria
    Czech Republic
    Finland
    Italy
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    Ukraine
    United Kingdom
    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
    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 months11
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days10
    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: 255
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 420
    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 Decision2019-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-11
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    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-Sat May 04 17:51:10 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA