Phase 2
Completed N=102
Open-label Study of Safety and Tolerability of Memantine in Children With Autism
Autism Spectrum Disorder · Pediatric Autism
Source: ClinicalTrials.gov NCT01999894 ↗
Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Mar 2014
Primary outcomePrimary: Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) — 85 participants
Summary
The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) |
85 | — |
Eligibility Criteria
Inclusion Criteria
- Completed lead-in study MEM-MD-57A (NCT00872898)
- A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
Exclusion Criteria
- Patients with a concurrent medical condition that might interfere with the conduct of the study
Data sourced from ClinicalTrials.gov (NCT01999894). 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.