drugset

drugset / Trial / NCT03887676

Arbaclofen vs. Placebo in the Treatment of Children and Adolescents With ASD (ARBA)

NCT03887676 ↗

Phase 2 Completed 90 enrolled Holland Bloorview Kids Rehabilitation Hospital McMaster University · collab Queen's University · collab Unity Health Toronto · collab University of Toronto · collab Western University, Canada · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will examine the safety and efficacy of arbaclofen vs. placebo on social function in children and adolescents with Autism Spectrum Disorder (ASD).

Timeline

Start: 2019-03-18
Primary completion: 2023-08-04
Completion: 2023-08-04

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Arbaclofen	Small molecule	5 mg	Oral
Comparator	Arbaclofen	Small molecule	10 mg	Oral
Comparator	Arbaclofen	Small molecule	15 mg	Oral
Comparator	Arbaclofen	Small molecule	20 mg	Oral

Indications