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

Stopped early · 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 objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

Key facts

Study ID

NCT01592773

Run by

Forest Laboratories

People needed

747

Starts

2012-10-01

Expected to finish

2014-03-01

Last updated by the study team

2015-02-16

Who can join

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

You may qualify if…

• Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
• Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.
• 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…

• Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
• 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
• Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (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 Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior

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 125 — Orlando, Florida, United States
• Forest Investigative Site 062 — Orlando, Florida, United States
• Forest Investigative Site 067 — Tampa, Florida, United States
• Forest Investigative Site 101 — Wellington, Florida, United States
• Forest Investigative Site 068 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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