Arbaclofen
Druginitial single dose arbaclofen
NCT Number: NCT07655115
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
Interested in participating?
Request Info0 year–64 year
All sexes
Interventional
Phase 3
Assistance Publique Hopitaux De Paris, Paris, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
initial single dose arbaclofen
initial single dose placebo
Time frame: baseline to day 7
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
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: from baseline to end of treatment
To explore the effect of arbaclofen on other measures of defining features of autism.
Time frame: baseline to day 7
To explore EEG marker sensitive to excitatory/inhibitory changes.
Hospital General Universitario Gregorio Marañon
Other
A Follow-Up Shiftability Study of Arbaclofen With an Open-Label Extension for the Study of Biomarkers in Children and Adolescents With Autism Spectrum Disorders.
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