Phase 2 N=44 Randomized Quadruple-blind Treatment

Sulforaphane-rich Broccoli Sprout Extract for Autism

Autism

Bottom Line

View on ClinicalTrials.gov: NCT01474993 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2014

Primary outcome: Primary: Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks — -7.79; -14.76; -1.38; -14.48 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sulforaphane-rich Broccoli Sprout Extract (Drug); Placebo (Drug)
Age: Pediatric, Adult · 13+ yrs
Sex: Male
Sponsor: Andrew Zimmerman
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks	-7.79; -14.76; -1.38; -14.48; -2.0; -20.40	—
SECONDARY Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks	0.77; -12.69; 3.31; -19.61; -2.0; -21.44	—
SECONDARY Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks	4.36; 4.38; 4.43; 4.31; 4.50; 4.42	—
SECONDARY Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks	4.14; 4.04; 3.86; 3.88; 3.93; 3.81	—
SECONDARY Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks	27.6; 23.8; 22.5; 22.5; 21.8; 25.4	—
SECONDARY Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks	0.8; 0.8; 0.8; 0.8; 0.8; 0.8	—
SECONDARY Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks	1.8; 1.8; 1.5; 1.9; 1.2; 1.7	—
SECONDARY Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks	5.13; 5.11; 5.03; 5.13; 5.12; 5.04	—
SECONDARY White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks	6.63; 6.32; 6.33; 5.94; 6.12; 6.18	—
SECONDARY Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks	242.1; 235.0; 236.8; 237.1; 218.1; 255.0	—
SECONDARY Change From Screening and Baseline in Urinary Isoprostane F2α-VI Levels at 24 Hours After First Dose, at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks	0.007; 0.017	—
SECONDARY Change From the Screening Visit in Heat Shock Protein Gene Expression (Relative Maximum Gene Expression) at 24 Hours After First Dose, 18 Weeks and 22 Weeks	-0.116; -0.0008	—

Summary

The primary objectives of this study are to answer whether there is evidence of measurable effects on social responsiveness (primary outcome) and other behavioral symptoms after treatment of autistic male adolescents and adults with orally administered sulforaphane-rich Broccoli Sprout Extract (efficacy). The secondary objectives of this study are to answer whether treatment of male adolescents and adults with autism using orally administered sulforaphane-rich Broccoli Sprout Extract within a specified dose range is safe (toxicity); treatment with sulforaphane-rich Broccoli Sprout Extract is well tolerated (side effects and adverse events); key cellular biomarkers support the hypothesized mechanisms (proof of principle).

Eligibility Criteria

Inclusion Criteria

Autism diagnosis. Quantitative autism traits and severity for diagnosis of autism will be assessed using the ADOS-G (Modules 1-4 and Severity), Social Responsiveness Scale (SRS; child and adult forms), Clinical Global Impression-Severity (CGI-S) and Aberrant Behavior Checklist-Withdrawal subscale (ABC-W).

Exclusion Criteria

Absence of a parent or legal guardian and consent
Unavailability for 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 (AST/ALT > 2x upper limit of normal), impaired thyroid function (TSH outside normal limits)
Current infection or treatment with antibiotics; AND
Chronic medical disorder (e.g., cardiovascular disease, stroke or diabetes) or major surgery within 3 months prior to enrollment.
A diagnosis of autism spectrum disorder other than autism, for example, Asperger's, PDD-NOS etc.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01474993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.