Status:
ENROLLING_BY_INVITATION
Validation Digital Bio-markers During Sulforaphane Treatment.
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Autism
Autism Spectrum Disorder
Eligibility:
MALE
13-30 years
Phase:
NA
Brief Summary
The purpose of the research is to determine if changes seen during sulforaphane treatment (a compound that comes from eating certain vegetables) can better be understood using digital biomarkers. Thes...
Detailed Description
This study is a pilot open label treatment trial with SF (sulforaphane) in 10 individuals that have completed with moderate to severe autism, age 13-30 years that have completed participation in Clini...
Eligibility Criteria
Inclusion
- Autistic disorder diagnosis.
- Age between 13-30 years.
- Male gender.
- Participated in clinical trial NCT02677051
Exclusion
- Those that started or continued taking Avmacol® or similar broccoli extracts since leaving our double-blind study.
- Absence of a parent or legal guardian and consent,
- Those that can not or will not complete all visits and adherence to study regimen.
- Seizure within 2 years of screening,
- History of chronic kidney, liver or thyroid disease.
- Impaired renal function (serum creatinine\> 1.2 mg/dl).
- Impaired hepatic function (\> 2x upper limit of normal).
- Impaired thyroid function (TSH outside normal limits).
- Current infection or treatment with antibiotics.
- Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major surgery within 3 months prior to enrollment.
- Less than 13 years or more than 30 years of age.
- Female gender.
- A diagnosis of autism spectrum disorder other than autistic disorder, for example, Asperger, PDD-NOS ( Pervasive Developmental Disorder-Not Otherwise Specified) etc.
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04805957
Start Date
July 7 2022
End Date
June 1 2027
Last Update
October 30 2025
Active Locations (1)
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1
Rutgers-RWJMS Department of Neurology
Piscataway, New Jersey, United States, 08854