An Open-Label Extension 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)

FOREST RESEARCH INSTITUTE0 个研究点目标入组 220 人开始时间: 2012年10月24日最近更新: 2014年6月16日

适应症

试验速览

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•1. The parents/guardian/LAR must provide written informed consent before the patient's participation in the study.2. 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. 3. Patients who completed Study MEM-MD-68 or MEM-MD-91. Patients who discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response. Sponsor approval is required before enrolling any other patient who discontinued a preceding memantine study. 4. Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1. 6. 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 7. 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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 110
•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

•1. Patients who discontinued a preceding memantine study due to an
•adverse event possibly related to study drug 2. 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 3. 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 4. 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 5. 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 6. Patients requiring treatment with prohibited concomitant medications 7. Patients who, in the opinion of the Investigator, might not be suitable for the study 8. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center

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