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    Summary
    EudraCT Number:2018-000064-28
    Sponsor's Protocol Code Number:RAP-MD-33
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-11-06
    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 ConcernedSweden - MPA
    A.2EudraCT number2018-000064-28
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel in the Prevention of Relapse in Patients with Major Depressive Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rapastinel Versus placebo to prevent relapse of Major depression
    A.4.1Sponsor's protocol code numberRAP-MD-33
    A.5.4Other Identifiers
    Name:INDNumber:136,870
    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 SponsorAllergan Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Sales LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointEU Global Clinical Trial Management
    B.5.3 Address:
    B.5.3.1Street AddressMarlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441628494444
    B.5.6E-mailML-RAP-MD-33@allergan.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 namerapastinel
    D.3.2Product code AGN-241659 (previously GLYX-13)
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRAPASTINEL
    D.3.9.2Current sponsor codeAGN-241659
    D.3.9.4EV Substance CodeSUB192215
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 150
    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.IMP: 2
    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 namerapastinel
    D.3.2Product code AGN-241659 (previously GLYX-13)
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRAPASTINEL
    D.3.9.2Current sponsor codeAGN-241659
    D.3.9.4EV Substance CodeSUB192215
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 150
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboIntravenous 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
    Moderate to severe depression
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    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
    To evaluate the efficacy of rapastinel (225 or 450 mg, IV, weekly or clinically driven schedule) versus placebo in the maintenance treatment of MDD, as measured by time to relapse during the 52 weeks of the double-blind treatment period (DBTP)
    E.2.2Secondary objectives of the trial
    To characterize the efficacy of rapastinel (225 or 450 mg, IV, weekly or clinically driven schedule) versus placebo in the maintenance treatment of MDD, as measured by change from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) at each postbaseline timepoint during the DBTP.

    To evaluate the safety and tolerability of rapastinel (225 or 450 mg, IV, weekly or clinically driven schedule) in the maintenance treatment of MDD, as evaluated by AEs, clinical laboratory measures, electrocardiograms (ECGs), vital signs, and Columbia-Suicide Severity Rating Scale (C SSRS).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic
    Sparse pharmacokinetic (PK) samples will be taken from patients
    consenting to optional PK sampling to determine plasma concentrations
    of rapastinel using a validated bioanalytical method.
    E.3Principal inclusion criteria
    1. Written informed consent, obtained from the patient before the initiation of any study specific procedures
    2. Completion of RAP-MD-30, RAP-MD-31, or RAP-MD-32. Note: because RAP-MD-30, RAP-MD-31, or RAP-MD-32 are conducted at different countries, only patients completing one of the studies approved by that country's competent authority will be eligible to participate in study RAP-MD-33.
    3. Male or female outpatients, 18 to 75 years of age (at time of entry to lead-in study)
    4. Normal physical-examination findings, clinical-laboratory test results, and ECG results from Visit 1 or abnormal results that are determined to be not clinically significant with regard to participation in the study by the investigator (Note: Because Visit 1 ECG and laboratory results will not be available on the day of Visit 1, patients can be discontinued at Visit 2 if upon receipt of results the investigator determines clinically significant abnormalities are present.)
    5. If female of childbearing potential, has a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test. Because Visit 1 pregnancy test results will not be available on the day of Visit 1, patients can be discontinued at Visit 2 if Visit 1 pregnancy test is positive.
    6. Ability to follow study instructions and likely to complete all required visits
    E.4Principal exclusion criteria
    1. Positive result at Visit 1 from the urine drug screen (UDS) test for any prohibited medication. Exception: patients with a positive UDS at Visit 1 for opiates or episodic use of benzodiazepines may be allowed in the study as described more detailed in the protocol
    (Note: Because Visit 1 UDS results will not be available on the day of Visit 1, patients can be discontinued at Visit 2 if upon receipt of results the investigator determines exclusionary results are present.)
    2. Suicide risk, as determined by meeting any of the following criteria:
    a. A suicide attempt within the past year
    b. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the C-SSRS at Visit 1
    c. MADRS Item 10 score ≥ 5 on the MADRS at Visit 1 of this study or at any visit during participation in the lead-in study
    3. At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator
    4. Requiring concomitant treatment with any of the prohibited medications, supplements, or herbal products listed in Appendix III, including any psychotropic drug or any drug with psychotropic activity except as described in Section 9.4.9.1.
    5. Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
    6. Females of childbearing potential, not using a highly effective means of contraception
    7. Any change in overall medical condition since entry in to the lead-in study that is determined by the investigator to be clinically significant with regard to participation in the study, including but not limited to: vital signs, ECG parameters, laboratory parameters, psychiatric status and neurological status
    8. Current enrollment in an investigational drug or device study or participation in such a study within 6 months of entry into this study with the exception of the lead-in rapastinel study (RAP-MD-30, RAP-MD-31, or RAP-MD-32)
    9. Employee, or immediate relative of an employee, of the sponsor, any of its affiliates or partners, or the study center
    10. Inability to speak, read, and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, or to allow the completion of all study assessments
    11. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
    E.5 End points
    E.5.1Primary end point(s)
    Time to first relapse during 52 weeks of the DBTP, defined as the number of days from the randomization date to the relapse date. Relapse during the DBTP is defined as meeting 1 or more of the following criteria within 52 weeks of randomization:
    - Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 18 at 2 consecutive visits, or
    - A ≥ 2 increase in Clinical Global Impressions-Severity (CGI-S) score compared with that obtained at randomization, or
    - Risk of suicide as determined by the investigator, or
    - Need for hospitalization due to worsening of depression as determined by the investigator, or
    - Need for alternative treatment of depressive symptoms as determined by the investigator
    E.5.1.1Timepoint(s) of evaluation of this end point
    Measured after subject´s first relapse that has occurred during the 52 weeks of the Double Blind Treatment Period.
    E.5.2Secondary end point(s)
    Additional efficacy endpoints:
    - MADRS change from baseline
    - CGI-S change from baseline
    - Sheehan Disability Scale (SDS) change from baseline

    Health Outcomes:
    - EuroQol-5 Dimensions Scale 5L Version (EQ-5D-5L)

    Safety:
    - Adverse event (AE) recording, clinical laboratory measures, vital sign parameters, electrocardiograms (ECGs), and physical examinations
    - Measure of sexual function: Changes in Sexual Functioning Questionnaire (CSFQ)
    - Measure of psychotomimetic effects: Brief Psychiatric Rating Scale Positive Symptoms subscale (BPRS+)
    - Measure of dissociative effects: Clinician Administered Dissociative States Scale (CADSS)
    - Measure of suicidality: Columbia-Suicide Severity Rating Scale (C-SSRS)
    - Measure of cognition/psychomotor function: Symbol Digit Coding (SDC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Additional efficacy endpoints:
    a change from baseline

    Health Outcomes
    Open-label: screening, week 8 and week 16
    Double-blind period: baseline, week 12, week 24, week 36, week 48 and week 52

    Safety:
    At each visit and the final analysis will be done at the end of the study
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Two treatment periods: Open-label (OLTP) 8-16 weeks followed by double-blind (DBTP) for 52 weeks
    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 trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Canada
    France
    Germany
    Hungary
    Italy
    Japan
    Poland
    Russian Federation
    Serbia
    Slovakia
    Spain
    Sweden
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 1260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 425
    F.4.2.2In the whole clinical trial 1400
    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 Decision2018-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-06-20
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