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    Summary
    EudraCT Number:2011-004494-81
    Sponsor's Protocol Code Number:PNB02-C201
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-11-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-004494-81
    A.3Full title of the trial
    Proof-of-Concept Study of Pipamperone 15mg added to Stable Treatment with Risperidone or Paliperidone in Chronic Schizophrenic and Schizoaffective Patients with Residual Symptoms: a phase I/IIa, randomized, double-blind, placebo-controlled trial of 7 weeks
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate if a low dose of pipamperone can improve the clinical outcome in patients with schizophrenia who are treated with stable antipsychotic medication but still have troublesome symptoms.
    A.4.1Sponsor's protocol code numberPNB02-C201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01450514
    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 SponsorPharmaneuroboost N.V.
    B.1.3.4CountryBelgium
    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 supportPharmaneuroboost N.V.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaneuroboost N.V.
    B.5.2Functional name of contact pointClinical Project Director
    B.5.3 Address:
    B.5.3.1Street AddressAlkerstraat 30A
    B.5.3.2Town/ cityAlken
    B.5.3.3Post codeB-3570
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32477636264
    B.5.5Fax number+3211484923
    B.5.6E-mailphilippe.lemmens@pharmaneuroboost.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 namepipamperone
    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 INNPIPAMPERONE HYDROCHLORIDE
    D.3.9.1CAS number 2448-68-2
    D.3.9.4EV Substance CodeSUB03835MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Schizophrenia or Schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-R criteria.
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10009134
    E.1.2Term Chronic schizophrenia
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039621
    E.1.2Term Schizoaffective disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    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 is to explore the effects of low dose (15mg/d) pipamperone (PIP) on functional MRI assessments and their correlation with any clinical outcome (see protocol in Appendix 1).
    E.2.2Secondary objectives of the trial
    The secondary objectives are (1) to explore to what extent adding 15mg/d of PIP to risperidone or paliperidone improves the clinical outcome of chronic schizophrenic or schizoaffective patients with residual symptoms and to what extent it affects standard safety assessments and adverse events over 6 weeks of treatment in comparison with risperidone or paliperidone alone, and (2) to explore the interaction of genetic variables with any clinical outcome when adding a low dose (15mg/d) of pipamperone (PIP) to stable treatment with risperidone or paliperidone.

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    As described in the secondary objective of the trial, pharmacogenetics are investigated in a sub-study of this trial. The details of the pharmacogenetics protocol is described in Appendix 2 of the Clinical Trial Protocol.
    E.3Principal inclusion criteria
    1. Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
    2. Patient understands the investigational nature of the trial and is willing and able to comply with the trial requirements.
    3. Patient is male or female, aged 18-65 years.
    4. Patient has Schizophrenia or Schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-R criteria. Diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI).
    5. Patient is being treated during at least 12 weeks with a stable dosage of either
    a/ Risperdal (TM) Consta (TM) (risperidone) of 12.5mg - 50mg (extremes included) IM every 2 weeks
    b/ Xeplion (TM) (paliperidone) of 25mg - 100mg (extremes included) IM every 4 weeks.
    c/ Risperidone oral administration of 2–6 mg/d
    d/ Paliperidone oral administration of 4-12 mg/d
    Stable treatment with a combination of risperidone and paliperidone, administered orally or IM, may be considered on an individual basis provided the cumulative exposure is not exceeded.
    6. Patient has a score of 4 or more on at least 1 item of the positive PANSS subscale.
    7. Patient has a score of 3 or more on CGI-S (at least ‘mildly ill’).
    E.4Principal exclusion criteria
    1. Patient with a documented (date, symtom description and intervention) acute exacerbation of his/her
    schizophrenic or schizoaffective disorder during the past 12 weeks,.
    2. Documented debility or an IQ below 85.
    3. Patient is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or who does not consistently use 2 combined effective methods of contraception (including at least 1 barrier method), unless sexually abstinent.
    4. Comorbid axis 1 conditions (including anxiety disorders, eating disorders, impulse control disorders) requiring newly initiated drug treatment during the 12 weeks prior to randomization.
    5. Patient has taken, in the past 6 weeks prior to randomization, any newly initiated
    psychoactive drug.
    6. Patient has a clinically relevant renal dysfunction (e.g. eGFR <50mL/min).
    7. Patient has hepatic dysfunction (total bilirubin >2.0mg/dL or alanine aminotransferase (ALT)
    and/or aspartate aminotransferase (AST) greater than 2 times the upper limit of the reference range).
    8. Patient has a malignant neoplastic disease, a documented history of epilepsy (juvenile convulsions excepted).
    9. Patient with a documented history or concomitant diagnosis or significant risk of cardiac arrhythmia or dysrhythmia, including a QTc interval of ≥500 ms at screening.
    10. Patient has any other medical or psychiatric condition, which in the opinion of the investigator, can jeopardize or would compromise the patient’s ability to participate in this trial or that would interfere with trial assessments.
    11. Patient with documented alcohol abuse (i.e., with concomitant out of range MCV and/or γGT), known drug abuse, or having a positive standard screen for alcohol or drugs (excluding benzodiazepines, opioids and amphetamines taken for more than 6 weeks prior to randomization and continued at an unchanged dosage).
    12. Patient was withdrawn from psychoactive drug treatment in the past week or within a period shorter than 5x the elimination half-life of any psychoactive drug. Withdrawal of any prior antipsychotic treatment should not have occurred within 6 weeks prior to baseline.
    13. Concomitant treatment with any additional antipsychotic drug (excepted when used at a subtherapeutic dosage, i.e., at a dosage below the recommended lowest effective antipsychotic dosage), diuretics, QT prolongation drugs, or dopamine agonists.
    14. Formal cognitive psychotherapy initiated during study treatment or within 6 weeks prior to randomization.
    15. Patient has participated in another trial of an investigational agent (including medical device) within the last month prior to baseline or is currently participating in another trial of an investigational drug.
    16. Known hypersensitivity to any of the study drugs.
    17. For those participating to MRI assessments:
    Any formal contraindication to perform Magnetic Resonance Imaging, including intracranial aneurysm clips, intra-orbital metal fragments, any electrically, magnetically or mechanically activated implants (including cardiac pacemakers, biostimulators, neurostimulators, cochlear implants, and hearing aids), and any non-removable metallic objects (including tattoos containing metal containing pigments).
    18. Patients who only participate to part 2 of the study are to be excluded if they are not treated with RIS IM or PAL IM.
    E.5 End points
    E.5.1Primary end point(s)
    Functional Magnetic Resonance Imaging
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening, Day 1, 2, 9, 10, 22 and 50
    E.5.2Secondary end point(s)
    CLINICAL EFFICACY VARIABLES:
    Investigator rated variables:
    • Clinical Global Impression of Improvement (CGI-I) score and end-of-study opinion whether active substance of placebo was administered
    • Positive and Negative Symptom Severity (PANSS) total score and subitem scores

    Cognitive assessment (by investigational staff):
    • Brief Assessment of Cognition in Schizophrenia (BACS)
    • Hopkins Verbal Learning Test – Revisited (LVLT-R)

    Patient reported outcome variables (patient self-assessment):
    •Subjective Well-being under Neuroleptics (SWN) score and subscale and subitem scores
    • Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR) and subscale and subitem scores
    • Patient’s Global Impression (PGI) and end-of-study opinion whether placebo or active substance was administered

    SAFETY VARIABLES:
    Investigator assessed/rated/collected variables:
    • Frequency, severity and relatedness of treatment-emergent adverse events (TEAEs) reported spontaneously by the patient or observed by the investigator; AEs of special interest: hyperprolactinaemia related AEs and possible extra-pyramidal symptom (EPS) related AEs.
    • Barnes Akathisia Rating Scale (BARS) total and subitem scoring
    • Overall clinical judgment of the Abnormal Involuntary Movement Scale (AIMS)
    • Physical examination
    • CGI-Safety assessment
    • Vital signs, body weight and body mass index (BMI)
    • Clinical laboratory values (hematology, serum chemistry, endocrine parameters, and urinalysis), including serum prolactin, fasting glucose and fasting lipids.
    • Triplicate12-lead ECG tracings

    ADDITIONAL EXPLORATORY VARIABLES:
    In addition to the Efficacy and Safety variables, a number of additional exploratory variables will be assessed as part of the functional imaging, pharmacogenetic research (optional) and PK/PD research activities. A separate protocol for imaging and pharmacogenetic research is available in Appendix. Results from imaging and pharmacogenetic research will be reported separately, as well as results from PK/PD analysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    EFFICACY VARIABLES:
    • CGI-I scores: Days 8, 21, 49
    • End-of-study opinion whether active substance or placebo was administered: Day 49
    • PANNS: screening, days 1, 8, 21, 49
    • BACS scores: Days 1, 2, 8, 9, 10, 22, 50
    • LVLT-R: Days 1, 2, 8, 9, 10, 22, 50
    • SWN scores: Days 1, 2, 8, 9, 10, 22, 50
    • IMI-SR scores: Days 1, 2, 8, 9, 10, 22, 50
    • PGI: Day 50

    SAFETY VARIABLES
    • TEAEs: Days 1, 2, 8, 9, 10, 21, 22, 49, 50
    • BARS score: Day 1, 8, 21, 49
    • AIMS: Day 1, 8, 21, 49
    • Physical examination: Screening, Day 49
    • CGI-Safety assessment: Day 49
    • Vital signs: sceening, Days 1, 2, 8, 9, 10, 21, 22, 49, 50
    • body weight, BMI: Screening, Days 1, 8, 21, 49
    • Clinical laboratory: Screening, Day 49
    • Triplicate 12-lead ECG: Screening, Days 1,2, 8, 9, 10, 21, 49
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 concerned10
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    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: 60
    F.1.3Elderly (>=65 years) No
    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 state60
    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)
    After completion of the clinical trial, patients will be treated according to the current state of the art therapy recommendations.
    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 Decision2012-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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