Autism Disorder Clinical Trial
Official title:
Magnetoencephalography / Magnetic Resonance Spectroscopy Dose Response Study of Arbaclofen in Autism Spectrum Disorder
This is a single-site, randomized, acute dose-response study to determine whether STX209 produces a dose-dependent significant change in MEG target parameters compared to baseline as well as compared to placebo treatment.
Recent evidence from magnetoencephalographic (MEG) studies in ASD have pointed to
abnormalities (specifically, delays) in auditory evoked neuromagnetic responses (e.g. M100 -
see Roberts et al., 2010, and mismatch field, MMF - see Roberts et al., 2011) as well as
abnormalities in the oscillatory behavior of auditory cortex, especially in the gamma band
(30-50Hz), at rest and in response to simple auditory stimuli (see Gandal et al., 2010 and
Cornew et al., 2012; Edgar et al., 2013). The local circuitry underlying such evoked activity
and oscillations, and synaptic transmission in general, requires an appropriate balance of
excitation and inhibition, mediated by glutamate and GABA, respectively. One model of the
neural oscillatory deficits in ASD suggests that impaired regulatory control by inhibitory
interneurons onto pyramidal cells underlies abnormal auditory latency and oscillatory
electrophysiological measures. As such, electrophysiological deficits are interpreted in
terms of local circuitry abnormalities, with inferences at the molecular level of imbalances
in the activity of glutamate and GABA.
A candidate therapeutic for ASD has been developed - STX209, a GABA-B agonist. Since this
pharmaceutical targets synaptic activity that has clear electrophysiological correlates, one
goal of this proposal is to assess the responsiveness (sensitivity to change) of MEG measures
to acute administration of STX209 at various doses in adolescents on the autism spectrum. The
study also aims to establish the nature of the putative relationship between such
electrophysiologic markers and GABA and glutamate levels using MEGAPRESS spectrally-edited
magnetic resonance spectroscopy (MRS).
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