Sulforaphane in a New Jersey (NJ) Population of Individuals With Autism

Rutgers The State University of New Jersey

Status and phase: Active, not recruiting; Phase 2

Conditions: Autistic Disorder; Autistic Behavior; Autism Spectrum Disorder; Autism

Treatments: Drug: Placebo; Drug: Sulforaphane

Study type: Interventional

Funder types: Other

Identifiers

NCT02677051

Pro20120001884

CAUT15APL013 (Other Grant/Funding Number)

Details and patient eligibility

About

This study is a double blind treatment trial that will test if sulforaphane improves core symptoms in autism. The investigators expect to see clinical improvement in some of these areas. Sulforaphanes come from eating certain vegetables such as broccoli. The investigators will be using a preparation that gives specific and reproducible amounts. The investigators will also test specific chemicals and genes needed for sulforaphane usage to try to understand differences in response.

Full description

This study is a double blind randomized treatment trial that will test if sulforaphane improves core symptoms in autism. It is designed to try to replicate a previous trial (ClinicalTrials.gov Identifier NCT01474993) which reported that the isothiocyanate, sulforaphane treatment led to improvement by multiple metrics. Significant improvement was seen in behavior as measured by the Aberrant Behavioral Checklist (ABC) and by the Social Responsiveness Scale (SRS). In addition a significantly greater number of participants receiving sulforaphane had improvement in social interaction, abnormal behavior, and verbal communication as per the Clinical Global Impression (CGI). In addition The investigators will attempt to account for some variability in response to sulforaphane treatment by testing alleles of genes that are relevant in sulforaphane metabolism. The investigators will also measure glutathione levels, which are also important in sulforaphane metabolism and are in part regulated by sulforaphane..

Sulforaphane is the most potent naturally occurring inducer of mammalian cytoprotective enzymes known. Therapeutic potential is based at least in part on their ability to up-regulate genes responsible for alleviation of oxidative stress and to regulate both the immune system and the inflammatory response

40 Males with autistic disorder will be randomly selected to receive either sulforaphane or placebo. Seven visits are required by the subjects including enrollment ,screening, baseline, weeks 4, 10 and 18 and a follow up visit at seek 22.

Enrollment: 48 patients

Sex: Male

Ages: 13 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Autistic disorder diagnosis.
• Age between 13-30 years.
• Male gender.

Exclusion criteria

• 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,
• 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, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

About 15 subjects will be randomized into this arm, receiving pills with an inactive placebo.

Treatment:

Drug: Placebo

Sulforaphane

Experimental group

Description:

About 30 subjects will be randomized into this arm, receiving pills with glucoraphanin rich broccoli seed powder containing active myrosinase resulting in sulforaphane once ingested Doses will be weight dependent with each pill resulting in \~ 50 µmol sulforaphane. Body weight Dose of sulforaphane 34 kg \~ 50 µmol 68 kg \~ 100 µmol 102 kg \~ 150 µmol

Treatment:

Drug: Sulforaphane