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    Summary
    EudraCT Number:2012-001616-33
    Sponsor's Protocol Code Number:MEM-MD-91
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-001616-33
    A.3Full title of the trial
    An Open-Label Study Of The Safety And Tolerability Of Memantine In
    Pediatric Patients With Autism, Asperger’s Disorder, Or Pervasive
    Developmental Disorder Not Otherwise Specified (PDD-NOS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Study Of The Safety And Tolerability Of Memantine In
    Pediatric Patients With Autism, Asperger’s Disorder, Or Pervasive
    Developmental Disorder Not Otherwise Specified (PDD-NOS)
    A.4.1Sponsor's protocol code numberMEM-MD-91
    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 SponsorForest Research Institute, 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 supportForest Research Institute United States
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles Contact Center
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressThe Alba Campus
    B.5.3.2Town/ cityRosebank, Livingston
    B.5.3.3Post codeEH54 7EG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number862 261 3634
    B.5.6E-mailQEudraCThelpdesk@quintilescontact.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 nameMemantine Hydrochloride
    D.3.2Product code MRZ 2/145
    D.3.4Pharmaceutical form Prolonged-release capsule
    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 INNMEMANTINE HYDROCHLORIDE
    D.3.9.1CAS number 41100-52-1
    D.3.9.4EV Substance CodeSUB03137MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autism or Asperger’s Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
    E.1.1.1Medical condition in easily understood language
    Autism
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10003484
    E.1.2Term Asperger's disorder
    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 LLT
    E.1.2Classification code 10008520
    E.1.2Term Childhood autism
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10034739
    E.1.2Term Pervasive developmental disorder NOS
    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 objective of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in the follow-up randomized withdrawal study
    E.2.2Secondary objectives of the trial
    not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in the study, patients must meet the following criteria:
    1. Provide written informed assent, when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. The parent/guardian/LAR must provide written informed consent before the patient’s participation in the study. A separate written informed consent for the caregiver must also be obtained before the conduct of any study specific procedures.
    2. Male or female outpatients
    3. Age of 6-12
    4. Females who are 9 years and older or who have had onset of menses must have a negative serum pregnancy test at screening
    5. Meet DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) diagnostic criteria for autism, Asperger’s Disorder, or PDD-NOS based on both:
    ○ ADOS (Autism Diagnostic Observation Schedule) Modules 2 or 3
    ○ ADI-R (Autism Diagnostic Interview–Revised)
    ADOS completed within the 6 months before Screening and ADI-R completed within the 3 months before Screening are acceptable provided that the assessments were done by a qualified rater. A copy of the scores must be available for the source file and the eCRF.
    6. Normal physical examination and laboratory test results at Screening (Visit 0) or any abnormal findings must be deemed not clinically significant by the Investigator and documented
    7. Normal sitting pulse rate by vital sign assessment. Any deviation from normal must be judged not clinically significant by the Investigator. Please refer to Appendix V for Normal ranges
    8. Normal sitting blood pressure (BP). Any deviation from normal must be judged not clinically significant by the Investigator.
    9. Ability to tolerate venipuncture procedures for blood sampling
    10. A knowledgeable caregiver capable of providing reliable information about the patient’s condition, able to attend all clinic visits with the patient, and able to oversee the administration of investigational product. Every effort should be made to maintain the same caregiver throughout the study
    11. Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study
    12. Be able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), as well as have a caregiver and parent/guardian/LAR who is able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), to comprehend the nature of the study and to allow for the completion of all study assessments
    13. Verbally fluent (at least three-word phrases). Must use some phrase speech if not verbally fluent
    14. An SRS (Social Responsiveness Scale) total raw score > 44 for females and > 53 for males
    15. An IQ in the not mentally retarded or mildly retarded range as measured by a standardized score of 50 or higher on the Kaufman Brief Intelligence Test, Version 2, or by other standard IQ test used for non-English speakers and in the countries outside the United States and Canada where the study is being conducted, at Screening (Visit 0)
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will not be eligible to participate in the
    study:
    1. Have enrolled in Study MEM-MD-57A
    2. History of premature birth (before 35 weeks gestational age or weight of < 5 lb at birth)
    3. History of hypersensitivity reaction to memantine, dextromethorphan, amantadine, or any other NMDA receptor antagonists
    4. Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger’s Disorder, and PDD-NOS
    5. Meeting DSM-IV-TR criteria for bipolar I disorder, psychotic disorder not otherwise specified, posttraumatic stress disorder, schizophrenia, or major depressive disorder within the past 6 months
    6. An ABC (Aberrant Behavior Checklist) Irritability subscale (ABC-I) score ≥ 17 at Screening (Visit 0)
    7. Significant risk of suicidality based on the investigator judgment, ABC-I, or if appropriate, as indicated by a response of “yes” to questions 3, 4, or 5 in the suicidal
    ideation section of the Children’s Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 0) or any suicidal behavior within the past 6 months.
    8. Taking, or having taken NMDA antagonists (eg, amantadine, ketamine, dextromethorphan) or any other excluded concomitant medications (Appendix III) within five half-lives or 4 weeks of Screening (Visit 0), whichever is shorter.
    9. Medical history of neurological disease including, but not limited to, movement disorder; Tourette syndrome; tuberous sclerosis; fragile X syndrome; velocardiofacial syndrome; chromosome 15q duplication syndrome; Angelman syndrome; active epilepsy/seizure disorder (defined as seizure activity within 5 years of screening (Visit 0) except simple febrile seizures; known abnormal computed tomography/magnetic resonance imaging of the brain; or a structural lesion of the brain
    10. Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient’s well-being. Such conditions include, but are not limited to, evidence or history of malignancy or any significant hematologic, endocrine, cardiovascular (including any rhythm
    disorder), respiratory, renal, hepatic, or gastrointestinal disease. If there is a history of such disease but the condition has been stable for more than 1 year and is judged by the Investigator not to interfere with the patient’s participation in the study, the
    patient may be included, with the documented approval of the Study Physician
    11. Clinically significant ECG abnormalities. Any deviation from normal must be judged not clinically significant by the Investigator. Please refer to Appendix V for out of normal ranges ECG values and findings
    12. Participation in any other clinical investigation using an experimental drug or requiring repeated blood draws within 30 days of the start of this study or participation in a blood donation program within the past 60 days
    13. Treatment with memantine or participation in an investigational study of memantine within 90 days of Screening (Visit 0)
    14. Female patients of child-bearing potential who are not using or not willing to use a conventional method of contraception approved by the PI. Abstinence is an acceptable method of contraception
    15. Patients who, in the Investigator’s and/or Sponsor’s opinion, might not be suitable for te study
    16. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center
    E.5 End points
    E.5.1Primary end point(s)
    1) Complete at least 12 weeks of exposure to investigational product and
    2) Meet the responder criterion at two consecutive visits separated by at least two weeks. A patient will be considered a responder if he or she presented at least 10 points improvement (reduction in score) in SRS relative to the Visit 1 total raw score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients meeting the confirmed responder criteria any time at or after Visit 5 (end of Week 12) will be expected to transition to a follow-up randomized withdrawal study (MEM-MD-68). SRS will be administered at Visits 0, 1, 4A, 5, 5A, 6, 6A, 7, 7A, 8, and confirmatory visits.
    E.5.2Secondary end point(s)
    No secondary objectives
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable as no secondary objectives
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Australia
    Belgium
    Colombia
    Denmark
    Finland
    France
    Germany
    Hungary
    Iceland
    Ireland
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    New Zealand
    Norway
    Philippines
    Poland
    Russian Federation
    Serbia
    Singapore
    South Africa
    Spain
    Sweden
    Taiwan
    Thailand
    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
    This study will be terminated when the required number of patients transition into the follow-up randomized withdrawal study. Patients active at the time of study termination will return to the site for final evaluations (Visit 8/ET) at the earliest opportunity and will be considered study completers, and will be eligible to continue in a follow-up open-label study.
    Forest, reserves the right to terminate the study in its entirety or at a specific study center before study completion.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 192
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 164
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The patient’s parent/guardian/LAR will provide informed consent. When determined the child is capable of assent, child assent will also be obtained.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 192
    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 meeting the confirmed responder criteria any time at or after Visit 5 will be expected to transition to a follow-up randomized withdrawal study MEM-MD-68. They will be randomized to one of three double-blind treatment arms (full or reduced dose, or placebo). Patients not meeting the SRS responder criteria will continue in this study until the Final Visit. Patients who are non-responders at the end of the study may be eligible to transition to a follow-up open-label study MEM-MD-69.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medicines for Children Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-16
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