Status:
WITHDRAWN
An Exploratory Open Label Study of EPI-743 (Vincerinone TM) in Children With Autism Spectrum Disorder
Lead Sponsor:
Edison Pharmaceuticals Inc
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
3-14 years
Phase:
PHASE2
Brief Summary
The investigators hypothesize that EPI-743 may provide clinical benefit to children with Autism Spectrum Disorder.
Detailed Description
An Exploratory Open Label Phase 2 Study of EPI-743 (Vincerinone TM) in Children with Autism Spectrum Disorder
Eligibility Criteria
Inclusion
- Diagnosis of Autism Spectrum Disorder as defined by the DSM-V criteria for ASD and a gold-standard diagnostic evaluation for ASD such as the Autism Diagnostic Observation Schedule (ADOS) and/or the Autism Diagnostic Interview - Revised (ADI-R)
- Male or female, 3 years to 14 years of age
- Abnormal glutathione cycle biomarkers (GSH/GSSG in plasma\<8.0)
- Language impairment (as defined by the CELF-2 or CELF-4 screener)
- Ability to complete language assessment (using either CELF or PLS)
- Subject or subject's guardian able to consent and comply with protocol requirements
- Abstention from use of Coenzyme Q10, vitamin E, lipoic acid, folinic acid, other forms of folic acid above recommended daily allowance (RDA), and idebenone 2 months prior to treatment with EPI-743 and for duration of study
- Stable regimen of medication and supplements for 2 months prior to enrollment and duration of the study
Exclusion
- Allergy to EPI-743 or sesame oil
- Allergy to vitamin E
- Clinical history of bleeding or abnormal baseline PT/PTT
- Use of anticoagulant medications
- Participation in any other interventional study within 90 days of treatment.
- Use of antipsychotic medications
- Moderate to severe positive response on ABC irritability subscale on questions: Injures self on purpose, is aggressive to other children or adults (verbally or physically), deliberately hurts himself/ herself, and/or does physical violence to self
- Severe impairment as defined as a Vineland Adaptive Behavioral Scales composite standard score of \<40
- Patients with genetic disease that gives rise to ASD (e.g. Rett syndrome, Down syndrome, fragile x syndrome)
- Abnormal liver function tests two times the upper limit of normal or renal insufficiency with creatinine levels two times the upper limit of normal
Key Trial Info
Start Date :
October 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02226458
Start Date
October 31 2014
End Date
January 31 2016
Last Update
January 21 2022
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