An interventional study of Arbaclofen_15 and Arbaclofen_30 in Autism Spectrum Disorder, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-22.
Sponsored by King's College London · Not applicable, Interventional, and Basic science
This study investigates the brain response to a single acute dose of Arbaclofen, the R-enantiomer of the GABA-B agonist Baclofen, compared to a single dose of placebo in healthy men with and without autism spectrum disorder.
Previous research suggests that GABAergic drug compounds could shift brain excitation and inhibition (E-I) in the healthy brain and in neurodevelopmental psychiatric conditions, such as autism spectrum disorder (ASD) - where this balance is disrupted. A study by Ajram et al. (2017) has shown an E-I shifted towards more GABA in individuals with ASD, and not in controls, after a single dose of the anti-glutamatergic and pro-GABAergic drug Riluzole. Moreover, brain connectivity patterns in ASD patients where shifted towards the ones observed in the control group. However, it was unclear whether this changes could be driven by GABA receptors, thus more specific probes may help to clarify the mechanism underlying the E-I coordination in ASD. Therefore, this study will use neuroimaging and electrophysiology to investigate the brain E-I coordination in ASD compared to control participants when the system is responding to a single dose of the specific GABA-B (STX209) receptor agonist. 50 adult individuals with ASD and 50 neurotypical adults (25 males and 25 females per group) will be invited to participate. Each participant will receive a single dose of the drug (15mg or 30mg Arbaclofen) or matched placebo). Brain activity and neurochemistry will be investigated using magnetic resonance imaging. Further data will be collected through questionnaires, behavioural tasks, blood samples, and sensory tasks using electroencephalography and retinal imaging.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 87 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
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Exclusion Criteria:
Dose order: Placebo, Arbaclofen 15mg, Arbaclofen 30mg
Drug: Arbaclofen_15 · Drug: Arbaclofen_30 · Drug: Placebo
Dose order: Placebo, Arbaclofen 30mg, Arbaclofen 15 mg
Drug: Arbaclofen_15 · Drug: Arbaclofen_30 · Drug: Placebo
Dose order: Arbaclofen 30mg, Placebo, Arbaclofen 15mg
Drug: Arbaclofen_15 · Drug: Arbaclofen_30 · Drug: Placebo
Dose order: Arbaclofen 15mg, Placebo, Arbaclofen 30mg
Drug: Arbaclofen_15 · Drug: Arbaclofen_30 · Drug: Placebo
Dose order: Arbaclofen 15mg, Arbaclofen 30mg, Placebo
Drug: Arbaclofen_15 · Drug: Arbaclofen_30 · Drug: Placebo
Dose order: Arbaclofen 30mg, Arbaclofen 15mg, Placebo
Drug: Arbaclofen_15 · Drug: Arbaclofen_30 · Drug: Placebo
Single oral dose (15mg)
Also known as: r-baclofen, STX209
Single oral dose (30mg)
Also known as: r-baclofen, STX209
Single oral dose placebo (oral tablet)
Also known as: Placebo oral tablet
Neurochemical response to GABAergic stimulation.
Comparing brain excitation-inhibition measures (i.e., glutamate and GABA) when the GABAergic system is activated by a single oral dose of the GABA-B drug Arbaclofen versus the placebo condition.
Time frame: Through study completion, an average of 2 years.
Functional connectivity measures using resting state functional magnetic resonance imaging.
Maps of functional connectivity will be obtained for each condition and compared between adults with and without ASD.
Time frame: Through study completion, an average of 2 years.
Brain oscillations under sensory stimulation
Brain oscillations and event-related potentials will be recorded during sensory stimulation using high density electroencephalography.
Time frame: Through study completion, an average of 2 years.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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King's College London