Sulforaphane-rich Broccoli Sprout Extract for Autism

NCT01474993 | Completed Phase 2 Results DMC

• 1 other identifier: 2011P002221
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

• Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks

  The Social Responsiveness Scale is a parent- and/or teacher-reported 65 question scale. Each question on the scale inquires about an observed aspect of reciprocal social behavior that is rated on the scoring sheet on a scale from "0" to "3", where 0 is best possible behavior and 3 is the worst possible behavior. The total SRS score may range from 0 to 195 where higher values represent the worse outcome. For the purposes of this study, SRS scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average SRS scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively.

  4 weeks, 10 weeks, 18 weeks and 22 weeks

Secondary Outcomes (11)

• Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks

  4 weeks, 10 weeks, 18 weeks, 22 weeks

• Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks

  4 weeks, 10 weeks, 18 weeks, 22 weeks

• Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks

  4 weeks, 10 weeks, 18 weeks, 22 weeks

• Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks

  4 weeks, 18 weeks, 22 weeks

• Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks

  4 weeks, 18 weeks, 22 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

inactive placebo.

Drug: Placebo

Interventional

EXPERIMENTAL

sulforaphane-rich Broccoli Sprout Extract.

Drug: Sulforaphane-rich Broccoli Sprout Extract

Interventions

Sulforaphane-rich Broccoli Sprout Extract DRUG

30 subjects will be randomly selected to receive sulforaphane-rich Broccoli Sprout Extract. The medication will be supplied and dispensed as No.1 size gelcaps (each gelcap containing \~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to \~ 50 µmol of sulforaphane). The dosage of sulforaphane will depend on subject's body weight: 1. Subjects with body weight less than 101 lbs will receive \~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day) 2. Subjects with body weight 101 lbs to 199 lbs will receive \~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day) 3. Subjects with bidy weight \> 199 lbs will receive \~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)

Interventional

Placebo DRUG

15 subjects will be randomly selected to receive inactive placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose)

Placebo

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrew Zimmerman: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Lurie Center for Autism, MassGeneral Hospital for Children

Lexington, Massachusetts, 02421, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Andrew Zimmerman, M.D.
• Organization: UMass Medical School

Andrew.Zimmerman@umassmemorial.org

508-856-3279

Study Officials

• Andrew W. Zimmerman, M.D.

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Neurologist

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 18, 2011
• Study Start: December 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 12, 2018
• Results First Posted: November 24, 2014

Record last verified: 2018-09

Locations

US (1)