Arbaclofen in Children and Adolescents With ASD

Summary

AIMS-2-CT-01 is a randomized, double-blind, placebo controlled, study to explore the efficacy, safety and tolerability of Arbaclofen administered to children and adolescents (ages 5-17) for the treatment of social adaptive function in participants with ASD. The effects of Arbaclofen on social function in children and adolescents with ASD will be evaluated in a randomized, placebo controlled, parallel-group study of 16 weeks duration. Subjects who meet protocol criteria will be randomly allocated to receive either Arbaclofen or placebo in a 1:1 ratio in the Treatment Period. There will be 7 recruiting sites and randomization will be stratified by site. A sample of 130 patients will be recruited. Blinding will be maintained by utilizing identical tablets containing either Arbaclofen or placebo.

Timeline

Start

2019-09-19

Primary completion

2023-01-27

Completion

2023-01-27

Publications

• Parellada M, San Jose Caceres A, Delorme R, Moscoso A, Moreno C, Calvo R, Canal-Bedia R, Franco Martin MA, Charman T, Strydom A, Parr JR, Urbiola Merino E, Burdeus-Olavarrieta M, Hernandez Jusdado P, Solis A, Lucas M, Sipos L, Gonzalez Navarro P, Blazquez A, Lazaro L, Tomas A, Humeau E, Antoun S, Cooke J, Megalogeni M, Liang H, de-Vena-Diez VB, Leonard H, White N, Wang P, Walton-Bowen K, Winter-van Rossum I, Murphy D, Arango C. Efficacy, safety, and tolerability of arbaclofen in Autistic children and adolescents, the AIMS-2-TRIALS-CT1: a randomized, double-blind, placebo-controlled phase II trial. EClinicalMedicine. 2026 Jan 22;92:103760. doi: 10.1016/j.eclinm.2026.103760. eCollection 2026 Feb.
• Parellada M, San Jose Caceres A, Palmer M, Delorme R, Jones EJH, Parr JR, Anagnostou E, Murphy DGM, Loth E, Wang PP, Charman T, Strydom A, Arango C. A Phase II Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Arbaclofen Administered for the Treatment of Social Function in Children and Adolescents With Autism Spectrum Disorders: Study Protocol for AIMS-2-TRIALS-CT1. Front Psychiatry. 2021 Aug 24;12:701729. doi: 10.3389/fpsyt.2021.701729. eCollection 2021.

Drugs

Indications