Sulforaphane for Autistic Disorder

Phase-Based Estimates
1
Effectiveness
1
Safety
Rutgers-RWJMS Department of Neurology, Piscataway, NJ
Autistic Disorder+3 More
Sulforaphane - DietarySupplement
Eligibility
< 65
Male
Eligible conditions
Autistic Disorder

Study Summary

This study is evaluating whether digital biomarkers can be used to better understand the effects of sulforaphane treatment.

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Eligible Conditions

  • Autistic Disorder
  • Disease
  • Autism Spectrum Disorder
  • Autism, Early Infantile

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Sulforaphane will improve 7 primary outcomes in patients with Autistic Disorder. Measurement will happen over the course of Week 16..

Week 16.
Aberrant Behavior Checklist (ABC)
Digital Biomarkers
EEG
EKG
Electrophysiological recordings.
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S, an autism specific version of the Clinical Global Impression, CGI)
Social Responsiveness Scale (SRS)

Trial Safety

Safety Estimate

1 of 3

Side Effects for

Sulpforaphane
Flatulence
35%
Nausea
35%
Dyspepsia
20%
Diarrhea
20%
Bloating
20%
Gatrointestinal pain
15%
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT01228084) in the Sulpforaphane ARM group. Side effects include: Flatulence with 35%, Nausea with 35%, Dyspepsia with 20%, Diarrhea with 20%, Bloating with 20%.

Trial Design

2 Treatment Groups

Control
Treatment

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sulforaphane is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Treatment
DietarySupplement
All subjects will receive 1.47umol/kg/day sulforaphane for 12 weeks. Pills are taken once a say with a meal.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulforaphane
2016
Completed Phase 3
~330

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 16.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 16. for reporting.

Who is running the study

Principal Investigator
E. B. T. P.
Prof. Elizabeth B. Torres Ph.D., Associate Professor of Psychology
Rutgers, The State University of New Jersey

Closest Location

Rutgers-RWJMS Department of Neurology - Piscataway, NJ

Eligibility Criteria

This trial is for male patients aged 65 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Autistic disorder diagnosis.
Age between 13-30 years.
Male gender.
Participated in clinical trial NCT02677051

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is autistic disorder?

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Attentional problems are present in more than half of those referred to ASHA clinics and about half of those assessed by clinicians and therapists working in community clinics have autistic spectrum disorders, which make up a considerable number of diagnoses.

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Can autistic disorder be cured?

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Parents should know that any purported cure for autism must be medically discredited as pseudoscientific, and medical treatment is not going to change the core, enduring issues in a child with autism.

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What causes autistic disorder?

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The overall effect of autism spectrum disorder is greater than the combined contribution of genetics and the environment. Thus, both genetic and environmental factors are involved in its development and presentation. However, the genes for autism are not fully understood. What is known about the genetics of ASDs is mostly based on a sample of single-gene, high-risk models in which the children had autistic symptoms. For example, the S-protein receptor (SORL1) is one gene that has been discussed as being involved in ASDs. Sorl1 is thought to play a role in the development of communication and social skills, and in particular in understanding facial expressions.

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How many people get autistic disorder a year in the United States?

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An estimated 1.3 million children and adults in the United States have autism spectrum disorder. The number of patients with autism spectrum disorder will not be known until the last decade of the 21st century.

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What are common treatments for autistic disorder?

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The prevalence of ASD is high and treatments for ASD are complex. There is scope for new approaches to treatment as ASD is known to have a number of possible treatments and symptomatology.

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What are the signs of autistic disorder?

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This paper describes the most common signs, and describes signs that occur in only a minority of patients. Some signs may occur in patients without any autistic symptoms, and these signs can appear for a longer period in this cohort than in the previous reports. In addition, some of the symptoms have a delay in onset that is longer than would be expected. Children with ASDs may have both symptoms of ASD and nonspecific cognitive symptoms, which affect their school readiness. Children with ASDs have a risk of poor social development, emotional disturbances, or social difficulties.

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Does sulforaphane improve quality of life for those with autistic disorder?

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The presence of Sulforaphane in plants is associated with decreased neurochemical effects, and it has improved quality of life in those with ASD. Longitudinal research is needed to determine whether the presence of Sulforaphane may decrease neurobehavioral symptoms in individuals with ASD.

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Who should consider clinical trials for autistic disorder?

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Results from three meta-analyses suggest that a higher frequency of trials is required among clinical trial registrants in order to assess the efficacy of autistic disorder agents systematically.

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What does sulforaphane usually treat?

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The use of SFN in the treatment of autism was based on case reports and experience with other diseases. There have been few randomized controlled trials done on this drug. Therefore, [it is difficult, if not impossible to generalize from case reports to a clinical situation]] to conclude that SFN is an effective treatment in autism.

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What is the average age someone gets autistic disorder?

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Based upon our data, we suggest that the average age of diagnosis of ASD is 8 years. This estimate is likely to be an under-estimate given that we did not investigate cases presenting before age 4. More studies are needed to further study this topic.

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Does autistic disorder run in families?

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There was no evidence of a familial aggregation in the current study, which suggests that the genetic predisposition to autism cannot be determined by looking at families in isolation. It may be of interest to study the genetic predisposition to ASD in the setting of other psychiatric disorders. (Trial registration number: ACTRN1258001062699.

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What is the primary cause of autistic disorder?

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The clinical features of autistic spectrum disorders can be highly variable, and the relative contribution of multiple etiologies is unclear. Several environmental risk factors have been proposed to be of the order of 25 to 50% in the general population. These include exposure to environmental toxins (teratogens), medical toxins, infectious agents (zoonoses), or infectious agents and autoimmune disorders (immune teratogens). Because the cause of autistic spectrum disorders does not seem to be environmental or genetic, it was previously thought that they were caused by an “essential malfunction in development”.

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