A Phase 2 interventional study of EPI-743 in Autism Spectrum Disorder, sponsored by Edison Pharmaceuticals Inc. Withdrawn. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by Edison Pharmaceuticals Inc · Phase 2, Interventional, and Treatment
The investigators hypothesize that EPI-743 may provide clinical benefit to children with Autism Spectrum Disorder.
An Exploratory Open Label Phase 2 Study of EPI-743 (Vincerinone TM) in Children with Autism Spectrum Disorder
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
Browse Autistic Disorder studies →Edison Pharmaceuticals Inc is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
15 mg/kg oral solution three times per day, maximum of 200 mg per dose
Drug: EPI-743
Also known as: Vincerinone TM
Primary Efficacy
Change in plasma levels of reduced and oxidized glutathione from baseline to six months
Time frame: 6 months
Secondary Endpoint
Change in language skills as assessed by change from baseline to six months on the Clinical Evaluation of Language Fundamentals or Preschool Language Scale
Time frame: 6 months
Secondary Endpoint
Change from baseline to six months in adaptive behavior and social skills as assessed by the Vineland Adaptive Behavior Scale-Second Edition (VABS), Social Responsiveness Scale (SRS), and computerized eye movement analysis
Time frame: 6 months
Secondary Endpoint
Change from baseline to six months in stereotyped behavior and associated ASD symptoms as assessed by Aberrant Behavior Checklist (ABC), The Ohio Autism Clinical Impression Scale (OACIS), Repetitive Behavior Scale - Revised (RBS-R) and Autism symptoms questionnaire (ASQ)
Time frame: 6 months
Secondary Endpoint
Change from baseline to six months in gastrointestinal function as assessed by Symptom Diary (stool frequency, abdominal symptoms and medications) and six-item GI severity index (6-GSI).
Time frame: 6 months
Secondary Endpoint
Change from baseline to six months in caregiver strain experienced by parents of children with emotional and behavioral disorders as assessed by Caregiver Strain Questionnaire (CGSQ)
Time frame: 6 months
Secondary Endpoint
Change from baseline to six months in intellectual function, attention and memory as assessed by Leiter-R test
Time frame: 6 months
Secondary Endpoint
Change from baseline to six months in biomarkers of oxidative stress
Time frame: 6 months
Secondary Endpoint
Pharmacokinetic Assessment of EPI-743 including maximal plasma concentration (Cmax), area under plasma concentration curve (AUC), apparent oral clearance, apparent volume of distribution and time to peak concentration
Time frame: 6 months
Safety Endpoint
To examine the safety of EPI-743 in subjects with Autism Spectrum Disorder by examining drug-related adverse and serious adverse events
Time frame: 8 months
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Edison Pharmaceuticals Inc