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    Summary
    EudraCT Number:2018-003251-37
    Sponsor's Protocol Code Number:ACP-103-054
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-07
    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 ConcernedFinland - Fimea
    A.2EudraCT number2018-003251-37
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive 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 to evaluate the safety of Pimavanserin therapy in subject with Major Depressive Disorder
    A.4.1Sponsor's protocol code numberACP-103-054
    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
    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
    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 evaluate the efficacy of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy and benefits of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy on the following:
    • Functional impairment
    • Clinician’s global impression of severity and improvement of depressive symptoms
    • Sexual functioning
    • Sleepiness
    • Treatment response and remission
    • Anxiety
    • Impulsiveness
    •Early response to treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Is a male or female ≥18 years of age
    2. Can understand the nature of the study and protocol requirements and is willing to comply with study drug administration requirements and discontinue prohibited concomitant medications
    3. Provides written informed consent to participate in the study
    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. Has a clinical diagnosis of major depressive disorder with or without anxious distress by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and confirmed by the Mini-International Neuropsychiatric Interview (MINI) during the screening period. Subject may have either recurrent or single episode of major depressive disorder.
    6. Is treated during the current major depressive episode with one of the following SSRI/SNRI antidepressants at a minimally effective dose for at least 8 weeks with at least the same stable dose over 4 weeks prior to the SAFER State versus trait, Assessability, Face validity, Ecological validity, and Rule of three Ps (pervasive, persistent, and pathological)
    remote interview:
    a. Citalopram
    b. Escitalopram
    c. Paroxetine
    d. Fluoxetine
    e. Sertraline
    f. Duloxetine
    g. Venlafaxine
    h. Desvenlafaxine
    I. Venlafaxine XR
    The dose level of the antidepressant is expected to remain stable throughout the study. Adherence to the antidepressant should be reviewed throughout the study.
    7. Must have a detectable blood level of a prescribed SSRI/SNRI during Screening. A negative screening test may be repeated as assessed by the Medical Monitor when the subject and/or site can provide additional evidence of subject adherence to antidepressant treatment or evidence of sample or laboratory error.
    8. During the screening period, the subject's inadequate response to SSRI/SNRI antidepressant treatment is confirmed by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH ATRQ) through the SAFER remote interview and the subject continues to exhibit an inadequate response to treatment at the time of
    the SAFER interview.
    9. Subjects who are currently taking a second antidepressant or antidepressant augmentation agent at a subtherapeutic dose or for inadequate duration at Screening are eligible for inclusion in the study if it is clinically appropriate to discontinue the drug before the Baseline visit (in the opinion of the Investigator); the second antidepressant/augmentation agent must be discontinued and washed out at least 5 half-lives prior to Baseline. This second antidepressant/augmentation agent should not be discontinued solely to make the subject eligible for enrollment in the study.
    10. Has a Montgomery-Asberg Depression Rating Scale (MADRS) total score >20 at both Screening and Baseline
    11. Has a Clinical Global Impression–Severity (CGI-S) score ≥4 (moderately ill or worse) for depression at both Screening and Baseline
    12. 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 for at least 1 month prior to Visit 2 (Baseline), 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 Has a history of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features, bipolar I or II disorder. Subjects who are currently being treated or require treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive compulsive disorder are also not eligible.
    2 Has a current primary diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder, according to DSM-5 criteria
    3 Has met DSM-5 criteria for substance use disorders within the last 6 months prior to Screening, except for disorders related to the use of caffeine or nicotine
    4 Is suicidal at Visit 1 (Screening) or Visit 2 (Baseline) as defined below:
    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 (Screening); OR
    c.Is actively suicidal in the Investigator’s judgment
    5. Has current evidence of delirium or an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies that, in the judgment of the Investigator or medical monitor , would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study
    6 Has a history of epilepsy
    7 Has atrial fibrillation unless adequately anti-coagulated
    8 Has a history of myocardial infarction, unstable angina, acute coronary syndrome, or cerebrovascular accident
    9 Has a history of any of the following:
    a Greater than New York Heart Association (NYHA) Class II congestive heart failure
    b Grade II or greater angina pectoris (by Canadian Cardiovascular Society Angina Grading Scale)
    c Sustained ventricular tachycardia
    d Ventricular fibrillation
    e Torsade de pointes
    f Syncope due to an arrhythmia
    g An implantable cardiac defibrillator
    10 Has laboratory evidence of hypothyroidism at Screening, as measured by thyroid stimulating hormone (TSH) and reflex free thyroxine (T4). If TSH is abnormal and the reflex free T4 is normal, the subject may be enrolled
    11 Has current unstable diabetes or glycosylated hemoglobin (HbA1c) >8% at Screening
    12 Has a known history of a positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) test
    13 Has a history of neuroleptic malignant syndrome or serotonin syndrome
    14 Has a known personal or family history of long QT syndrome or family history of sudden cardiac death
    15 Has any of the following ECG results at Visit 1 (Screening) or Visit 2 (Baseline):
    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
    At Screening, if the set of triplicate ECGs has a prolonged QTcF due to an identifiable cause, and it is medically appropriate to address that cause, a repeat set of triplicate ECGs may be performed during Screening at the discretion of the Medical Monitor.
    16 Has a heart rate <50 beats per minute as measured by peripheral pulse rate, not explained by regular exercise or medication in discussion with the Medical Monitor. If bradycardia is secondary to iatrogenic or treatable causes and these causes are treated, a heart rate assessment can be repeated during the screening period.
    17 Requires treatment with a medication or other substance that is prohibited by the protocol
    18 At Screening, has a body mass index (BMI) <18.5 kg/m2 or >35 kg/m2
    19 Has a positive test for an illicit drug or cannabis at Screening or Baseline. Subjects who test positive for a controlled substance and who have a valid prescription may be retested during Screening if they agree to abstain from the medication for the length of their participation in the study. The repeat test during Screening must be negative for them to participate in the study. Additionally, DSM-5 criteria for substance use disorders should not be met.
    20 Has received electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation, or has received deep brain stimulation in the current episode of depression
    21 Has received new-onset psychotherapy or had a change in the intensity of psychotherapy within 8 weeks prior to Screening
    22 Has participated in or is participating in a noninterventional study or clinical trial of any investigational or marketed drug, device, or intervention, within 30 days or 5 half lives, whichever is longer, of Visit 2
    23 Has previously been enrolled in any prior clinical study with pimavanserin or is currently taking pimavanserin
    24 Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline in the Hamilton Depression Scale (17 items) (HAMD 17) total score
    E.5.1.1Timepoint(s) of evaluation of this end point
    After final Database lock
    E.5.2Secondary end point(s)
    •Change from Baseline in Sheehan Disability Scale (SDS) score
    •Change from Baseline in Clinical Global Impression–Severity (CGI-S) score for depressive symptoms
    •Clinical Global Impression–Improvement (CGI-I) score for depressive symptoms
    •Change from Baseline in the Changes in Sexual Functioning Questionnaire Short Form (CSFQ-14)
    •Change from Baseline in Karolinska Sleepiness Scale (KSS) 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. Treatment remission is defined as a HAMD-17 total score ≤7.
    •Change from Baseline in the Hamilton Depression (HAMD) Anxiety/Somatization factor score
    •Change from Baseline in the Barratt Impulsiveness Scale (BIS-11)
    •Change from Baseline to Week 1 in the HAMD-17 total 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 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 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 concerned6
    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
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 280
    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 6 week double-blind treatment period may have the opportunity to enroll in the 1 year open label extension study ACP-103-055
    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 Decision2019-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-05-29
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