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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
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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).
Behavioral improvements occur transiently during febrile illnesses in autism, and include decreased repetitive behaviors and improved speech. These changes have been recorded in 38% of autistic children in a clinical survey and 83% in an observational study, respectively. The cellular basis for this "fever effect" is unknown but is likely to involve heat shock proteins (HSP) and cellular stress responses (CSR) that lead to changes in synaptic function and network connectivity.
Sulforaphane (1-isothiocyanato-4R- (methylsulfinyl)butane) is an isothiocyanate that is delivered by lyophilized extracts of 3-day-old broccoli sprouts. Broccoli sprouts are widely consumed as a food item all over the world by very large numbers of individuals, without any reports of adverse effects. Our preliminary work in vitro shows that sulforaphane stimulates HSP and mitochondrial biogenesis in several genetic disorders.
This study of sulforaphane-rich Broccoli Sprout Extract in autism is a randomized, double-blinded, placebo-controlled, phase II single site trial, designed to ensure safety and obtain efficacy data, with a focus on changes in social responsiveness, a core feature of autism. Its hybrid design, incorporating double masking, placebo control, and randomization, enhances the robustness of early outcome data. The study duration will be 2 years. Recruitment of subjects will be 50% by 8 months and complete by 14 months. All subjects in the study will be followed for 22 weeks. Treatment (18 weeks) will be started as patients are entered into the study and receive baseline testing. All treatment will be completed by 20 months and data analysis and presentation of results by 24 months.
Forty-five male adolescents (13-18 years) and adults (19-30 years) with autism will be randomly assigned to receive either sulforaphane-rich Broccoli Sprout Extract (n = 30) or placebo (n = 15). The 2:1 randomization schedule will be produced by the study statistician using permuted random blocks and stratification by history of positive behavioral effects of fever. Treatment assignments will be performed by the research pharmacy at MGH. Females will be excluded for homogeneity of the sample and because males have higher incidence of autism than females (4:1). We will seek to enroll up to 50% of the subjects having a history of positive behavioral effects of fever, which will be recorded from caregivers' recall of incidents and graded on the CGI-Improvement (CGI-I) 7-point scale.
There will be in total 7 study visits for each subject: the screening visit, enrollment visit, a blood draw visit at 24 hours after the first dose of study medication (for mitochondrial/heat shock protein analysis), 4 week (follow-up) visit, 10 week (follow-up) visit, 18 week visit (last treatment visit), and the final closeout visit one month after the study drug stops (22 weeks). Even though the treatment will stop at 18 weeks, we will follow subjects for additional 4 weeks after study medication stops (the 22 week visit) to ensure safety after study drug stops. Additional visits may be conducted in case any side effects are reported at any stage of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | inactive placebo. |
|
| Interventional | Experimental | sulforaphane-rich Broccoli Sprout Extract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | The Aberrant Behavior Checklist has 58 questions rated by parents or teachers on a scale of 0 to 3, where a score of "0" for particular behavior is not a problem at all, "1" indicates that the behavior is a problem but slight in degree, "2" indicates that the problem is moderately serious, and "3" indicates that the problem is severe in degree. The possible ABC scores may range from 0 to 174, where higher values represent the worse outcome. For the purposes of this study, ABC 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 ABC scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew W. Zimmerman, M.D. | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurie Center for Autism, MassGeneral Hospital for Children | Lexington | Massachusetts | 02421 | United States |
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Forty-four study participants were initially enrolled in the study from January 2011 to July 2013 at Lurie Center for Autism.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 15 participants were randomized to placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose).One participant in placebo group dropped out before starting study drug. 14 participants completed the study. |
| FG001 | Sulforaphane-rich Broccoli Sprout Extract | 29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study. Sulforaphane-rich Broccoli Sprout Extract: The medication was 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 depended on subject's body weight:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 15 participants were randomized to placebo. |
| BG001 | Sulforaphane-rich Broccoli Sprout Extract | 29 subjects were randomized to receive sulforaphane. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks, 10 weeks, 18 weeks and 22 weeks |
|
22 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 15 participants were randomized to placebo. One participant in placebo group dropped out before starting study drug. 14 participants completed the study and were analyzed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Zimmerman, M.D. | UMass Medical School | 508-856-3279 | Andrew.Zimmerman@umassmemorial.org |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| 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) |
|
| 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 | OACIS-S is a 10 domain scale that requires the clinician to rate the severity of the patient's autism symptoms at the time of assessment. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests. Each domain is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | 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 | The Ohio Autism Clinical Impressions Improvement Scale (OACIS-I) is a 10 domain scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests. Each domain is rated on a scale of 1 to 7, where "1" is very much improved; "2" is much improved; "3" is minimally improved; "4" is no change; "5" is minimally worse; "6" is much worse; or "7" is very much worse. | 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 |
| Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks |
| Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks |
| White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks |
| Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks | 4 weeks, 18 weeks, 22 weeks |
| 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 | *Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported. | Screening, baseline, 24 hours after first dose of study medication, 4 weeks, 10 weeks, 18 weeks, 22 weeks |
| 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 | Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported. | Screening, 24 hours after first dose of study medication, 18 weeks, 22 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Aberrant Behavior Checklist total score | The Aberrant Behavior Checklist has 58 questions rated by parents or teachers on a scale of 0 to 3, where a score of "0" for particular behavior is not a problem at all, "1" indicates that the behavior is a problem but slight in degree, "2" indicates that the problem is moderately serious, and "3" indicates that the problem is severe in degree. The possible ABC scores may range from 0 to 174, where higher values represent the worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Social Responsiveness Scale total score | 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. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S general level of autism score | This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about the overall level of autism. The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S social interaction score | This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about social interaction impairment. The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S aberrant behavior score | This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires aberrant behaviors (such as aggressions etc.). The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S repetitive behavior score | This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about repetitive/ritualistic behaviors. The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S verbal communication score | This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about impairment of verbal communication skills. The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S nonverbal communication score | This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about impairment of non-verbal communication skills. The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S hyperactivity/inattention score | This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about severity of hyperactivity and inattentiveness. The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S anxiety score | This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about severity of anxiety. The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S sensory sensitivity score | This question on the Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about severity of sensory sensitivities. The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| OACIS-S restricted interests score | This question on Ohio Autism Clinical Impressions Scale - Severity (OACIS-S) inquires about restricted and narrow interests of the patient. The question is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Mean | Standard Deviation | units on a scale |
|
| Hematology: Red Blood Cell (RBC) counts | Mean | Standard Deviation | *10^6 cells/µL |
|
| Hematology: White Blood Cell (WBC) counts | Mean | Standard Deviation | *10^03 cells/µL |
|
| Hematology: platelet counts | Mean | Standard Deviation | *10^03 cells/µL |
|
| Blood chemistry: serum creatinine | Mean | Standard Deviation | mg/dL |
|
| Blood Chemistry: Serum glutamic oxaloacetic transaminase (SGOT) | Mean | Standard Deviation | U/L |
|
| Blood Chemistry: Serum glutamic pyruvic transaminase (SGPT) | Mean | Standard Deviation | U/L |
|
| Blood chemistry: Thyroid Stimulating Hormone (TSH) | Mean | Standard Deviation | uIU/mL |
|
| Placebo |
Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day. |
| OG001 | Sulforaphane-rich Broccoli Sprout Extract | Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day. |
|
|
| Secondary | Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | The Aberrant Behavior Checklist has 58 questions rated by parents or teachers on a scale of 0 to 3, where a score of "0" for particular behavior is not a problem at all, "1" indicates that the behavior is a problem but slight in degree, "2" indicates that the problem is moderately serious, and "3" indicates that the problem is severe in degree. The possible ABC scores may range from 0 to 174, where higher values represent the worse outcome. For the purposes of this study, ABC 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 ABC scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks, 10 weeks, 18 weeks, 22 weeks |
|
|
|
| Secondary | Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | OACIS-S is a 10 domain scale that requires the clinician to rate the severity of the patient's autism symptoms at the time of assessment. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests. Each domain is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks, 10 weeks, 18 weeks, 22 weeks |
|
|
|
| Secondary | Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks | The Ohio Autism Clinical Impressions Improvement Scale (OACIS-I) is a 10 domain scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests. Each domain is rated on a scale of 1 to 7, where "1" is very much improved; "2" is much improved; "3" is minimally improved; "4" is no change; "5" is minimally worse; "6" is much worse; or "7" is very much worse. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks, 10 weeks, 18 weeks, 22 weeks |
|
|
|
| Secondary | Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks | Posted | Mean | Standard Deviation | U/L | 4 weeks, 18 weeks, 22 weeks |
|
|
|
| Secondary | Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks | Posted | Mean | Standard Deviation | mg/dL | 4 weeks, 18 weeks, 22 weeks |
|
|
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| Secondary | Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks | Posted | Mean | Standard Deviation | uIU/mL | 4 weeks, 18 weeks, 22 weeks |
|
|
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| Secondary | Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks | Posted | Mean | Standard Deviation | *10^6 cells/µL | 4 weeks, 18 weeks, 22 weeks |
|
|
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| Secondary | White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks | Posted | Mean | Standard Deviation | *10^3 cells/µL | 4 weeks, 18 weeks, 22 weeks |
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| Secondary | Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks | Posted | Mean | Standard Deviation | *10^3 cells/µL | 4 weeks, 18 weeks, 22 weeks |
|
|
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| 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 | *Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported. | *Due to lack of resources and issues with participant compliance, only the results on change from screening at the final intervention visit (18 weeks) in 13 placebo recipients are reported. | Posted | Mean | Standard Deviation | pG/mL | Screening, baseline, 24 hours after first dose of study medication, 4 weeks, 10 weeks, 18 weeks, 22 weeks |
|
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| 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 | Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported. | Posted | Mean | Standard Deviation | fold change | Screening, 24 hours after first dose of study medication, 18 weeks, 22 weeks |
|
|
|
| 0 |
| 14 |
| 4 |
| 14 |
| EG001 | Sulforaphane-rich Broccoli Sprout Extract | 29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study and were analyzed. | 0 | 26 | 5 | 26 |
| Increased aggressions | Psychiatric disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Increased Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Increased irritability | Psychiatric disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Seasonal allergy exacerbation | General disorders | Systematic Assessment |
|
| Seizures | Nervous system disorders | Systematic Assessment |
|
| Increased stubbornness | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Increased agitation | Psychiatric disorders | Systematic Assessment |
|
| Crying spells | Psychiatric disorders | Systematic Assessment |
|
| Hyperactivity | Psychiatric disorders | Systematic Assessment |
|
| Increased appetite | General disorders | Systematic Assessment |
|
| Increased anxiety | Psychiatric disorders | Systematic Assessment |
|
| Lethargy | Psychiatric disorders | Systematic Assessment |
|
| Increased burping | Gastrointestinal disorders | Systematic Assessment |
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| Abnormal platelet count | Investigations | Systematic Assessment |
|
| Abnormal WBC count | Investigations | Systematic Assessment |
|
| SGPT outside of reference range | Investigations | Systematic Assessment |
|
| SGOT outside of reference range | Investigations | Systematic Assessment |
|
| TSH outside of reference range | Investigations | Systematic Assessment |
|
Not provided
Not provided
| Change from screening/baseline at 18 weeks |
|
| Change from screening/baseline at 22 weeks |
|
| OACIS-S general level of autism 18 weeks |
|
| OACIS-S general level of autism 22 weeks |
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| OACIS-S social interaction 4 weeks |
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| OACIS-S social interaction 10 weeks |
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| OACIS-S social interaction 18 weeks |
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| OACIS-S social interaction 22 weeks |
|
| OACIS-S aberrant behavior 4 weeks |
|
| OACIS-S aberrant behavior 10 weeks |
|
| OACIS-S aberrant behavior 18 weeks |
|
| OACIS-S aberrant behavior 22 weeks |
|
| OACIS-S repetitive behavior 4 weeks |
|
| OACIS-S repetitive behavior 10 weeks |
|
| OACIS-S repetitive behavior 18 weeks |
|
| OACIS-S repetitive behavior 22 weeks |
|
| OACIS-S verbal communication 4 weeks |
|
| OACIS-S verbal communication 10 weeks |
|
| OACIS-S verbal communication 18 weeks |
|
| OACIS-S verbal communication 22 weeks |
|
| OACIS-S non-verbal communication 4 weeks |
|
| OACIS-S non-verbal communication 10 weeks |
|
| OACIS-S non-verbal communication 18 weeks |
|
| OACIS-S non-verbal communication 22 weeks |
|
| OACIS-S hyperactivity 4 weeks |
|
| OACIS-S hyperactivity 10 weeks |
|
| OACIS-S hyperactivity 18 weeks |
|
| OACIS-S hyperactivity 22 weeks |
|
| OACIS-S anxiety 4 weeks |
|
| OACIS-S anxiety 10 weeks |
|
| OACIS-S anxiety 18 weeks |
|
| OACIS-S anxiety 22 weeks |
|
| OACIS-S sensory sensitivity 4 weeks |
|
| OACIS-S sensory sensitivity 10 weeks |
|
| OACIS-S sensory sensitivity 18 weeks |
|
| OACIS-S sensory sensitivity 22 weeks |
|
| OACIS-S restricted interests 4 weeks |
|
| OACIS-S restricted interests 10 weeks |
|
| OACIS-S restricted interests 18 weeks |
|
| OACIS-S restricted interests 22 weeks |
|
| OACIS-I general level of autism 18 weeks |
|
| OACIS-I general level of autism 22 weeks |
|
| OACIS-I social interaction 4 weeks |
|
| OACIS-I social interaction 10 weeks |
|
| OACIS-I social interaction 18 weeks |
|
| OACIS-I social interaction 22 weeks |
|
| OACIS-I aberrant behavior 4 weeks |
|
| OACIS-I aberrant behavior 10 weeks |
|
| OACIS-I aberrant behavior 18 weeks |
|
| OACIS-I aberrant behavior 22 weeks |
|
| OACIS-I repetitive behavior 4 weeks |
|
| OACIS-I repetitive behavior 10 weeks |
|
| OACIS-I repetitive behavior 18 weeks |
|
| OACIS-I repetitive behavior 22 weeks |
|
| OACIS-I verbal communication 4 weeks |
|
| OACIS-I verbal communication 10 weeks |
|
| OACIS-I verbal communication 18 weeks |
|
| OACIS-I verbal communication 22 weeks |
|
| OACIS-I non-verbal communication 4 weeks |
|
| OACIS-I non-verbal communication 10 weeks |
|
| OACIS-I non-verbal communication 18 weeks |
|
| OACIS-I non-verbal communication 22 weeks |
|
| OACIS-I hyperactivity 4 weeks |
|
| OACIS-I hyperactivity 10 weeks |
|
| OACIS-I hyperactivity 18 weeks |
|
| OACIS-I hyperactivity 22 weeks |
|
| OACIS-I anxiety 4 weeks |
|
| OACIS-I anxiety 10 weeks |
|
| OACIS-I anxiety 18 weeks |
|
| OACIS-I anxiety 22 weeks |
|
| OACIS-I sensory sensitivity 4 weeks |
|
| OACIS-I sensory sensitivity 10 weeks |
|
| OACIS-I sensory sensitivity 18 weeks |
|
| OACIS-I sensory sensitivity 22 weeks |
|
| OACIS-I restricted interests 4 weeks |
|
| OACIS-I restricted interests 10 weeks |
|
| OACIS-I restricted interests 18 weeks |
|
| OACIS-I restricted interests 22 weeks |
|
| SGOT 22 weeks |
|
| SGPT 4 weeks |
|
| SGPT 18 weeks |
|
| SGPT 22 weeks |
|
| Serum Creatinine at 22 weeks |
|
| TSH 22 weeks |
|
| RBC count at 22 weeks |
|
| WBC count at 22 weeks |
|
| Platelet count at 22 weeks |
|