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    Summary
    EudraCT Number:2017-000163-32
    Sponsor's Protocol Code Number:NorPEPS
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-02-08
    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 ConcernedNorway - NOMA
    A.2EudraCT number2017-000163-32
    A.3Full title of the trial
    The Norwegian Prednisolone in Early Psychosis Study - NorPEPS

    The role of immune-modulating strategies in the treatment of psychosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Norwegian Prednisolone in Early Psychosis Study - NorPEPS

    The role of immune-modulating strategies in the treatment of psychosis
    A.4.1Sponsor's protocol code numberNorPEPS
    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 SponsorHelse-Bergen HF
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHelse Vest RHF
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelse Bergen HF
    B.5.2Functional name of contact pointErik Johnsen
    B.5.3 Address:
    B.5.3.1Street AddressHaukelandsveien 22
    B.5.3.2Town/ cityBergen
    B.5.3.4CountryNorway
    B.5.6E-mailerik.johnsen@helse-bergen.no
    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 Yes
    D.2.1.1.1Trade name Prednisolon Alternova
    D.2.1.1.2Name of the Marketing Authorisation holderAlternova AS
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 namePrednisolon Alternova
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboTablet
    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, schizophreniphorm disorder, schizoaffective disorder, psychosis NOS.
    E.1.1.1Medical condition in easily understood language
    Schizophrenia, psychosis-related disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    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 of this trial is to investigate whether prednisolone improves overall symptom severity as compared to placebo when given for 3 days in a dosage of 40 mg and subsequently tapered during 6 weeks in addition to antipsychotic medication to patients with early-stage psychotic disorder. We expect to find an improvement of symptoms as measured by the Positive And Negative Syndrome Scale (PANSS) compared to baseline, over the course of 6 weeks (Kay et al., 1987).
    E.2.2Secondary objectives of the trial
    Secondary objectives concern PANSS-scores after 6 and 12 months of follow up, improvement in cognitive functioning as measured by the Brief Assessment of Cognition in Schizophrenia (BACS). In addition, the positive and negative symptoms as well as general psychopathology (through PANSS subscales) are compared between treatment groups, next to general functioning using the GAF (Global Assessment of Functioning) (Karterud, 1998). Severity of depression will be assessed using the Calgary Depression Scale for Schizophrenia (CDSS) (Addington et al., 1990). Also the characteristics of patients (potentially) benefiting more from immunemodulation will be investigated through the assessment of a broad panel of immune parameters in blood. Finally, safety data will be evaluated by comparing incidences (number and % of subjects with at least one occurrence) of key SAEs and SUSARs between both groups, e.g. hospitalisations.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or
    schizoaffective disorder) or 298.9 (psychosis NOS)
    2. Onset of psychosis no longer than 5 years ago
    3. Minimum total PANSS score of 60 Age 18 -70 years.
    4. Patients are treated with antipsychotic medication
    5. Plasma level of CRP is > 3.9 mg/L at screening (through ‘high sensitivity’ measurement)
    6. Written informed consent is obtained
    7. Female patients of childbearing potential need to utilize a proper method of contraception
    (the pill, vaginal ring, hormonal patch, intrauterine device, cervical cap, condom,
    contraceptive injection, diaphragm) in case of sexual intercourse during the study.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study in case of:
    1. Presence of any of the contra-indications of prednisolone as reported in the SPC.
    2. Presence of diabetes mellitus or random (non-fasting) glucose levels exceeding 11 mmol/L at screening, severe heart failure, severe osteoporosis or systemic fungal infections.
    3. Body Mass Index (BMI) of >27.5
    4. Current or chronic use of systemic glucocorticosteroids (temporary use is permitted, if stopped before start of treatment trial)
    5. Chronic use of non-steroidal anti-inflammatory drugs, defined as daily use during more than 2 months. Intermittent use is permitted, if stopped at least 1 month before start of treatment trial.
    6. Pregnancy or breast-feeding. A urine pregnancy test will be performed at screening.
    7. Concurrent use of certain types of medication:
    1. liver enzyme inducing medication such as carbamazepine, riphampicine, primidone, barbiturates and phenytoine
    2. HAART (both HIV protease inhibitors and (non)-nucleoside reverse transcriptase inhibitors), especially efavirenz, ritonavir and lopinavir.
    3. telaprevir and boceprevir in treatment of Hepatitis C
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is overall symptom severity as measured with the Positive and Negative Syndrome Scale (PANSS) total score (Kay et al., 1987). We will compare the effect of prednisolone versus placebo, both given in addition to antipsychotic medication, with regards to change in overall symptom severity
    E.5.1.1Timepoint(s) of evaluation of this end point
    measured after 6 weeks of treatment compared to baseline
    E.5.2Secondary end point(s)
    Secondary study parameters include PANSS total scores 6 months after start of the treatment, neurocognitive functioning as measured with the Brief Assessment of Cognition in Schizophrenia (BACS) and symptom severity as measured with the PANSS subscales: the positive scale, negative scale and general psychopathology scale. Furthermore, general functioning will be evaluated using the split- GAF (Karterud, 1998). These parameters will be compared between patients treated with prednisolone versus placebo. Various serum and peripheral blood mononuclear cells will be collected from all patients at baseline, as well as after 3 and 6 weeks of treatment and after 6 months of follow up. Furthermore, severity of depression will be assessed and compared between groups using the CDSS. The need to adjust current antipsychotic medication with 25% or more of the dose in Defined Daily Doses (DDD) is compared between groups. Finally, safety data will be assessed by comparing incidences (number and % of subjects with at least one occurrence) of key SAEs and SUSARs between both groups, e.g. hospitalisations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PANSS total scores 6 months after start of the treatment
    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 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) 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 concerned3
    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
    LSLV
    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 months
    E.8.9.1In the Member State concerned days
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 88
    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)
    None
    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 Decision2017-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-01-25
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