Phase 2
Completed N=4
Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism
Source: ClinicalTrials.gov NCT00872898 ↗Enrolled (actual)
4
Serious AEs
0.8%
Results posted
Jan 2014
Primary outcomePrimary: Extent of Absorption of Memantine (Part One) — 682.53 ng•h/mL
Summary
The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extent of Absorption of Memantine (Part One) |
682.53 | — |
| PRIMARY Change in Total Raw Score of Social Responsiveness Scale |
-9.5; -9.6 | 0.9781 |
| SECONDARY Core Autism Treatment Scale-Improvement: Total Score |
50.4; 48.3 | 0.1197 |
| SECONDARY Core Autism Treatment Scale-Improvement: Social Interaction |
32.4; 31.1 | 0.1459 |
| SECONDARY Core Autism Treatment Scale-Improvement: Communication |
18.0; 17.2 | 0.1344 |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale |
-0.4; -0.7 | 0.7000 |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale |
-1.1; -1.2 | 0.9069 |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale |
-0.2; -0.5 | 0.4679 |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale |
-1.2; -1.2 | 0.9598 |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale |
-0.8; -0.9 | 0.9898 |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale |
-1.0; -0.5 | 0.4228 |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale |
-1.5; -0.2 | 0.0201 sig |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale |
-0.7; -0.9 | 0.6889 |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale |
-1.0; -0.8 | 0.7481 |
| SECONDARY Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale |
-0.5; -0.5 | 0.9500 |
Eligibility Criteria
Inclusion Criteria
- Males or females ages 6 to 12 years
- Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 & 3).
- A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
- Patients over age 12, only if they completed Study MEM-PK-21
Exclusion Criteria
- Medical history of active epilepsy/seizure disorder except simple febrile seizures
- Participation in any other clinical investigation using an experimental drug within 30 days of the start of this study
Data sourced from ClinicalTrials.gov (NCT00872898). 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. Informational only — not medical advice.