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    Summary
    EudraCT Number:2005-006048-42
    Sponsor's Protocol Code Number:P04628
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-006048-42
    A.3Full title of the trial
    A Phase 2a, Multiple-Dose, Placebo Controlled, Randomized, Two Way Crossover Study to Assess the Efficacy of SCH 420814 in Reducing Anti-Psychotic-Induced Extra-Pyramidal Symptoms Among Subjects With Schizophrenia and Schizoaffective Disorders
    A.4.1Sponsor's protocol code numberP04628
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSchering-Plough Research Institute
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameSCH 420814
    D.3.2Product code SCH 420814
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 377727-87-2
    D.3.9.3Other descriptive nameSCH 420814
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboCapsule*
    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
    Patients with schizophrenia and schizoaffective disorders experiencing anti-psychotic-induced extra-pyramidal symptoms.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10039626
    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 if anti-psychotic-induced extra-pyramidal symptoms can be reduced by SCH 420814 at the dose of 25mg BID.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of SCH 420814 as an adjunct to anti-psychotic therapy. To document the pharmacokinetics of SCH 420814.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Males/Females 18-65 years old with BMI 17-31.
    2)Subjects with DSM-IV criteria of schizophrenia and schizoaffective (depressive type) disorder with anti-pyschotic-induced Extrapyramidal Symptoms (EPS), such as parkinsonism and/or akathisia and/or dystonia and/or tardive dyskinesia (TD) based on developed ESRS criteria:a)An ESRS score of 2 on 2 items or a score of 3 or greater on one item is required to establish a presence of parkinsonism; b) An ESRS score of 2 on 2 items or a score of 3 or greater on one item is required to establish a presence of dystonia; c) An ESRS score of 2 on 2 items or a score of 3 or greater on one item is required to establish a presence of TD; d) An ESRS score of 3 or greater on the two items is required to establish a presence of akathisia; e) subjects must have a minimum total score the ESRS of 8.
    3)To enter the treatment phase of the study, subjects must be receiving neuroleptics (haloperidol, cyamemazine, tiapride, sulpiride, levomepromazine, perphenazine, perazine, melperone, promethazine, pipameperone, chlorprothixene, chlorpromazine or Risperidone), at a stable dosage for at least 7 days prior to enrollment. Other neuroleptics that have caused ESP may be considered after discussion between sponsor and site.
    4)Clinical laboratory tests must be within normal limits or clincally acceptable to the investigator. All subjectsshould have their liver function tests within normal limits on screening.
    5)Drug screen for drugs with a high potential for abuse must be negative.
    6)Subjects must be free of any clinically significant disease other than schizophrenia and schizoaffective (depressive type) disorder that would interfere with the study evaluation of procedures.
    7)Subjects must have a level of understanding sufficient to communicate with the research staff and to cooperate with all tests and examinations required by the protocol and be able to adhere to protocol restrictions and schedules.
    8)Subjects must be able to understand the nature of the study and must be willing to sign an informed consent (required for each subject and/or the subject's authorized legal reporesentative) prior to study enrollment.
    9)Physical exam must be within normal limits or clinically acceptable to the investigator/sponsor (except signs and symtpoms of of schizophernia and schizoaffective disorder).
    10)Females must have a FSH>/=40 IU/L and last menses or surgically sterilized must be greater than 12 months.
    11)The electrocardiogram (12-lead recorded at 25 mm/s and reporting ventricular rate and PR, QRS, QT and QTc intervals) must be clinically acceptable.
    E.4Principal exclusion criteria
    1)Subjects who have a history of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration.
    2)Subjects who have participated in a clinical trial of an investigational drug within 60 days prior to the start of the study.
    3)Subjects who have a clinically significant history of food or drug allergy.
    4)Subjects who have donated blood within the preceding 90 days.
    5)Subjects with circulating HIV, hepatitis C antibodies, or hepatitis B surface antigen.
    6)Subjects who are allergic to SCH 420814 or are allergic to any of the excipients in SCH 420814 capsules (citric acid, lactose monohydrate, croscarmellose sodium, magnesium stearate [nonbovine, vegetable grade], FD&C blue, titanium dioxide, gelatin-NF).
    7)Females who are not surgically sterilized or postmenopausal.
    8)Male subjects who are sexually active and who do not agree to use a barrier method of birth control during the study an for 30 days after the study.
    9)Subjects with severe/uncontrolled hypertension will be excluded. Subjects with hypertension well controlled on a stable dose of standard antihypertensive medication for at least 4 weeks before randomization are eligible.
    10)Subjects with history of coronary artery disease including MI, or cerebrovascular disease (stroke, TIA), or peripheral arterial disease.
    11)Subjects with atrioventricular (AV) block, sick sinus syndrome, congestive heart failure, or subjects with ECGs consistent with ischemic heart disease, or significant Q waves.
    12)Subjects with a history of any of the following: seizures, alcohol/drug dependence, previous neurosurgery.
    13)Subjects with DSM-IV criteria of dementia (except due to Schizophrenia and Schizoaffective disorder), or individuals who in the opinion of the investigator are not able to understand and/or comply to the study procedures and/or the instructions of the staff or are socially incapable to participate in the study. Vulnerable subjects (eg, subjects kept in detention) will be excluded from study participation.
    14)Individuals who do not comply with the requirement that he or she should not have used any drugs (except acetaminophen and other allowed medications) within two weeks prior to the study nor alcohol or caffeine/xanthine containing products (chocolates, wine, beer) within 72 hours prior to drug administration. Smoking will be allowed during the study and the washout periods to the extent that it does not interfere with the assessments and sample collections. Caffeinated and decaffeinated beverages will be allowed during the study and the washout periods.
    15)Subjects who were judged clinically to be at suicidal risk too serious to be included in this study.
    16)Subjects who had received electroconvulsive therapy (ECT) within 30 days before randomization.
    17)Subjects who are currently taking Clozapine will be excluded from study participation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the lowest ESRS total score within the 6-hour range on day 14.
    The secondary efficacy end points include each lowest sub-score within the 6-hour range on day 14, each sub-score at hours 1, 2, 3, 4, 5, 6 on day 14, the total score at hours 1, 2, 3, 4, 5, 6 on day 14, and the time-weighted average total score on day 14.

    Pharmacokinetic: The derived pharmacokinetic parameters (AUC and Cmax) will be listed and concentration data will be tabulated by each sampling time.

    Exploratory Analyses: The percent improvement from baseline in ESRS scores on day 14 (ie. 20% improvement, 30% improvement, etc) along with the 95% confidence interval will be summarized by the treatments. A regression type analysis may be carried out to evaluate a possible relationship between the efficacy endpoints and SCH 420814 concentrations / PK parameters.
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.1.6Cross over Yes
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 trial is over once the last enrolled subject completed Period 2 (Day 22 visit).
    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 months0
    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 months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2006-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-06
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