A Phase 3 interventional study of Arbaclofen and Placebo in Autism Spectrum Disorders, sponsored by Hospital General Universitario Gregorio Marañon. Recruiting at 5 sites in 2 countries. Open to participants aged 0 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Hospital General Universitario Gregorio Marañon · Phase 3, Interventional, and Treatment
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
Exclusion Criteria:
Drug: Arbaclofen
Other: Placebo
initial single dose arbaclofen
initial 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.
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
Plan to share: Yes — De-identified data will be entered in a GDPR compliant EDC by individual sites, and after thorough checks shared with the sponsor, according to the CTA. Data will possibly be shared after thorough data cleaning and checks of de-identification of individuals, with other parties of the consortium, if participants have agreed to that in the Informed Consent Form. Examples of these data would be EEG data, that would be uploaded in a secured server, and analysed by a consortium partner.
Supporting information: Csr
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Hospital General Universitario Gregorio Marañon