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
Signed Written Informed Consent a.Participants or their legal representative must have signed and dated an IRB/IEC approved written informed consent form
Diagnosis of an Autism Spectrum Disorder according to the DSM-5 criteria
Participation in the AIMS-2 CT1 (ages at recruitment 5 to 17).
Current pharmacological treatment regimen affecting behaviour has been stable for at least 6 weeks prior to screening and is expected to be stable during the duration of the study
Participants with any condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
Participants who are currently receiving treatment with racemic baclofen, vigabatrin, tiagabine, or riluzole or other GABA-related medications (e.g. gabapentin or pregabalin) other than arbaclofen in the context of AIMS-2 CT1
Participants who are currently receiving pharmacologic treatment affecting behaviour (see concomitant medication section) need to have a stable dose during the 6 weeks prior to the screening visit and for the duration of the study.
Participating in programs including non-pharmacologic educational, behavioural, and/or dietary interventions affecting behaviour, participation in these programs must have been continuous during the 3 months prior to screening and participants or their parent/caregiver/LAR may not electively initiate new or modify ongoing interventions for the duration of the study. Typical school vacations are not considered modifications of stable programming
Crossover
Arbaclofen
Druginitial single dose arbaclofen
Placebo
Other interventioninitial single dose placebo
Change 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.
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.
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.
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.
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Hospital General Universitario Gregorio Marañon
Lead sponsor
Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
Collaborator
