CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 25 enrolled
Drug / intervention
STX209 (15mg) +2 moredrug
Likely dose
STX209 (15mg)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02278328
NCT02278328Early Ph 1Completed
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Magnetoencephalography / Magnetic Resonance Spectroscopy Dose Response Study of Arbaclofen in Autism Spectrum Disorder

Timothy Roberts·interventional·Posted Oct 30, 2014·Updated Oct 21, 2019

In Brief

A Early Phase 1 clinical trial evaluating STX209 (15mg), placebo, and 1 other intervention for Autism Disorder. Completed, enrolled 25 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Disorder
CountriesUnited States
CollaboratorsSimons Foundation, Clinical Research Associates, LLC

Timeline

Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 30, 2014
Enrollment StartFeb 1, 2016
Primary CompletionJul 30, 2018
Study CompletionSep 27, 2019
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.7 years ago

Interventions

STX209 (15mg)drug

A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Each participant will receive a single dose of placebo in random order and a single dose of STX209 from smallest to largest (15mg, and 30mg). MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate. The STX209 (15mg) intervention is the "low dose"

placebodrug

A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Each participant will receive a single dose of placebo in random order and a single dose of STX209 from smallest to largest (15mg, and 30mg). MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate. The placebo intervention is the non-active placebo control dose

STX209 (30mg)drug

A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Each participant will receive a single dose of placebo in random order and a single dose of STX209 from smallest to largest (15mg, and 30mg). MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate. The STX209 (30mg) intervention is the "high dose"