Phase 2
N=903
An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Autism Spectrum Disorder (ASD) · Autism · Autistic Disorder · Asperger's Disorder · Asperger's
Bottom Line
View on ClinicalTrials.gov: NCT01592786 ↗Enrolled (actual)
903
Serious AEs
0.7%
Results posted
Aug 2014
Primary outcome: Primary: Number of Confirmed Social Responsiveness Scale (SRS) Responders — 517; 351 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Memantine Hydrochloride (HCl) (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Forest Laboratories
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Confirmed Social Responsiveness Scale (SRS) Responders |
517; 351 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01592786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.