A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of theSafety and Efficacy of Memantine in Pediatric Patients with Autism,Asperger's Disorder, or Pervasive Developmental Disorder Not OtherwiseSpecified (PDD-NOS) Previously Treated with Memantine

Conditions: Autism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
MedDRA version: 14.1Level: LLTClassification code 10008520Term: Childhood autismSystem Organ Class: 100000004852
MedDRA version: 14.1Level: PTClassification code 10003484Term: Asperger's disorderSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1Level: LLTClassification code 10034739Term: Pervasive developmental disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders

Registration Number: EUCTR2012-001568-31-IT

Lead Sponsor: FOREST RESEARCH INSTITUTE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 96

Inclusion Criteria

1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 2. Met responder criterion at two consecutive visits separated by at least two weeks in lead-in study MEM-MD-91 (at least a 10 point reduction in SRS total raw score relative to Visit 1 of MEM-MD-91) 3. The parents/guardian/LAR must provide written informed consent before the patient's participation in the study.4. Parents who are capable of providing reliable information about the patient's condition, attending all clinic visits with the patient, and overseeing the administration of study drug.5. Have normal results from the physical examination, laboratory tests, ECG, and vital signs at Visit 1 of this study (last visit of Study MEM-MD- 91). Any abnormal findings must be deemed not clinically significant by the Investigator and documented 6. Be able to speak and understand Italian sufficiently, as well as have parents who are able to speak and understand Italian sufficiently to comprehend the nature of the study and to allow for the completion of all study assessments 7. 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 8. Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1
Are the trial subjects under 18? yes
Number of subjects for this age range: 96
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being 2. Significant risk of suicidality based on the Investigator's judgment, ABC-I, or if appropriate, as indicated by a response of ''yes'' to questions 4 or 5 in the suicidal ideation section of the Children's C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior 3. Patients with evidence or history of malignancy (other than excised basal cell carcinoma) or any significant hematologic, endocrine, cardiovascular (including any rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease 4. 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 5. Patients requiring treatment with prohibited concomitant medications 6. Patients who, in the opinion of the Investigator, might not be suitable for the study 7. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) previously on stable memantine therapy utilizing a randomized withdrawal paradigm.;Secondary Objective: not applicable;Primary end point(s): Standard safety assessments are being conducted to align with the main objective of the study stated above. The primary outcome measure in this study will be the proportion of patients meeting the criterion for Loss of Therapeutic Response (LTR). LTR is defined as worsening (increase) of at least 10 points in the SRS total raw score relative to the score at Visit 1 (randomization) of this study.;Timepoint(s) of evaluation of this end point: Visit 2 (End of Week 2) Visit 3 (End of Week 4) Visit 4 (End of Week 6) Visit 5 (End of Week 8) Visit 6 (End of Week 10) Visit 7 (End of Week 12)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Children's Communication Checklist-2 (CCC-2) (Change from baseline in 10 subscales of the CCC–2);Timepoint(s) of evaluation of this end point: Visit 4 (End of Week 6) Visit 7 (End of Week 12/Final Visit/Early Termination)

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