Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism

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.

Timeline

Start

2009-04

Primary completion

2012-08

Completion

—

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo vs Memantine; p = 0.9781; Least squares mean difference -0.1 (95% CI -7.2 to 7.0); NCT00872898 ↗

paper There was no clear evidence of a difference between memantine and placebo with respect to severity of core symptoms of autism PMID 36006807 ↗

Publications

• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
• Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Memantine	Unknown	3 mg	Oral
Subject	Memantine	Unknown	6 mg	Oral
Subject	Memantine	Unknown	9 mg	Oral
Subject	Memantine	Unknown	15 mg	Oral

Indications