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.
Phase:
Phase 2
Details
Lead Sponsor:
Celso Arango, MD, PhD Inge Winter
Collaborators:
Hospital General Universitario Gregorio Marañon UMC Utrecht