study with arbaclofen (4 weeks of titration and then 6 weeks of active/stable treatment). The effects of arbaclofen on target EEG and ERG metrics will be associated with the clinical response in measures of social and general function, adaptive behaviour, social anxiety, sensory behaviours, global functioning, and quality of life in Children and Adolescents with Autism Spectrum Disorders
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
initial single dose arbaclofen
initial single dose placebo
Assistance Publique Hopitaux De Paris
Paris, France
RECRUITINGHospital Clinic De Barcelona
Barcelona, Spain
RECRUITINGHospital General Universitario Gregorio Marañón
Madrid, Spain
RECRUITINGHospital Universitario De Salamanca
Salamanca, Spain
RECRUITINGComplejo Asistencial De Zamora Hospital Provincial De Zamora
Zamora, Spain
RECRUITINGChange in power in the low frequency bands (theta/alpha) (between visits 1 and 2).
To predict long term response to arbaclofen based on a single dose response during the placebo-controlled randomized single dose double blind stage.
Time frame: baseline to day 7
Latency of N170 change (between visits 1 and 2).
To test the effect of arbaclofen on an EEG biomarker for response to faces during the placebo-controlled randomized single dose double blind stage.
Time frame: baseline to day 7
Change of Autism Impact Measure (AIM total (Kanne et al., 2014b, Silkey et al., 2023) and subscales. • Change in the Social Responsiveness Scale (SRS total and subscales; Constantino & Gruber, 2012a).
To explore the effect of arbaclofen on other measures of defining features of autism.
Time frame: from baseline to end of treatment
Change in power in the higher frequency bands (gamma/beta); connectivity in the theta and alpha bands; (between visits 1 and 2).
To explore EEG marker sensitive to excitatory/inhibitory changes.
Time frame: baseline to day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.