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

FOREST RESEARCH INSTITUTE0 个研究点目标入组 96 人开始时间: 2012年10月22日最近更新: 2014年2月17日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: FOREST RESEARCH INSTITUTE
入组人数: 96

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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

排除标准

•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

研究者

发起方

FOREST RESEARCH INSTITUTE

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A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients with Autism,Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with MemantineAutism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with MemantineMedDRA version: 14.1Level: LLTClassification code 10008520Term: Childhood autismSystem Organ Class: 100000004852MedDRA version: 14.1Level: PTClassification code 10003484Term: Asperger's disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 14.1Level: LLTClassification code 10034739Term: Pervasive developmental disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders

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A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients with Autism,Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with MemantineAutism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with MemantineMedDRA version: 14.1Level: PTClassification code 10003484Term: Asperger's disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 14.1Level: LLTClassification code 10008520Term: Childhood autismSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: LLTClassification code 10034739Term: Pervasive developmental disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders

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