An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Completed · Phase 2

Conditions studied: Autism Spectrum Disorder (ASD), Autism, Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

In brief

The purpose 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 a follow-up randomized withdrawal study.

Key facts

Study ID

NCT01592786

Run by

Forest Laboratories

People needed

906

Starts

2012-06-01

Expected to finish

2013-08-01

Last updated by the study team

2014-08-07

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female outpatients.
• Age of 6-12.
• Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
• 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

You may not qualify if…

• Have enrolled in Study MEM-MD-57A
• Medical conditions that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well-being.
• Participation in any other clinical investigation using an experimental drug within 30 days of screening.
• Having any primary psychiatric (Axis I) diagnosis other than autism, Asperger's Disorder, and PDD-NOS.
• 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

Where it is running

• Forest Investigative Site 005 — Phoenix, Arizona, United States
• Forest Investigative Site 055 — Tucson, Arizona, United States
• Forest Investigative Site 077 — Little Rock, Arkansas, United States
• Forest Investigative Site 054 — Glendale, California, United States
• Forest Investigative Site 109 — Imperial, California, United States
• Forest Investigative Site 066 — Irvine, California, United States
• Forest Investigative Site 096 — Los Angeles, California, United States
• Forest Investigative Site 021 — San Francisco, California, United States
• Forest Investigative Site 026 — Santa Ana, California, United States
• Forest Investigative Site 002 — Stanford, California, United States
• Forest Investigative Site 078 — Boulder, Colorado, United States
• Forest Investigative Site 073 — Centennial, Colorado, United States
• Forest Investigative Site 052 — Washington D.C., District of Columbia, United States
• Forest Investigative Site 075 — Bradenton, Florida, United States
• Forest Investigative Site 080 — Gainesville, Florida, United States
• Forest Investigative Site 117 — Jacksonville, Florida, United States
• Forest Investigative Site 065 — Maitland, Florida, United States
• Forest Investigative Site 118 — Miami, Florida, United States
• Forest Investigative Site 085 — Oakland Park, Florida, United States
• Forest Investigative Site 115 — Orange City, Florida, United States
• Forest Investigative Site 124 — Orlando, Florida, United States
• Forest Investigative Site 125 — Orlando, Florida, United States
• Forest Investigative Site 062 — Orlando, Florida, United States
• Forest Investigative Site 114 — Orlando, Florida, United States
• Forest Investigative Site 068 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.