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Sulforaphane-rich Broccoli Sprout Extract for Autism

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ClinicalTrials.gov Identifier: NCT01474993
Recruitment Status : Completed
First Posted : November 18, 2011
Results First Posted : November 24, 2014
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Andrew Zimmerman, University of Massachusetts, Worcester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autism
Interventions Drug: Sulforaphane-rich Broccoli Sprout Extract
Drug: Placebo
Enrollment 44
Recruitment Details Forty-four study participants were initially enrolled in the study from January 2011 to July 2013 at Lurie Center for Autism.
Pre-assignment Details  
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description 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.

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:

  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)
Period Title: Overall Study
Started 15 29
Completed 14 26
Not Completed 1 3
Reason Not Completed
Lost to Follow-up             1             2
Adverse Event             0             1
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract Total
Hide Arm/Group Description 15 participants were randomized to placebo. 29 subjects were randomized to receive sulforaphane. Total of all reporting groups
Overall Number of Baseline Participants 15 29 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 29 participants 44 participants
16.6  (3.5) 17.9  (3.9) 17.4  (3.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 29 participants 44 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
15
 100.0%
29
 100.0%
44
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 29 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   6.7%
1
   3.4%
2
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   6.9%
2
   4.5%
White
13
  86.7%
26
  89.7%
39
  88.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   6.7%
0
   0.0%
1
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 29 participants 44 participants
15 29 44
Aberrant Behavior Checklist total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
60  (23.2) 63.6  (25.3) 62.3  (24.4)
[1]
Measure Description: 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.
Social Responsiveness Scale total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
120.1  (16.6) 122.2  (24.1) 121.5  (21.6)
[1]
Measure Description: 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.
OACIS-S general level of autism score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.53  (0.74) 4.38  (0.56) 4.43  (0.62)
[1]
Measure Description: 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.
OACIS-S social interaction score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.80  (1.01) 4.51  (0.69) 4.61  (0.81)
[1]
Measure Description: 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.
OACIS-S aberrant behavior score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.20  (1.37) 4.21  (0.86) 4.20  (1.05)
[1]
Measure Description: 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.
OACIS-S repetitive behavior score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.13  (0.83) 4.14  (0.74) 4.13  (0.77)
[1]
Measure Description: 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.
OACIS-S verbal communication score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.53  (1.36) 4.45  (0.95) 4.48  (1.09)
[1]
Measure Description: 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.
OACIS-S nonverbal communication score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.27  (0.96) 4.10  (0.72) 4.16  (0.81)
[1]
Measure Description: 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.
OACIS-S hyperactivity/inattention score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.40  (0.91) 4.10  (0.90) 4.20  (0.90)
[1]
Measure Description: 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.
OACIS-S anxiety score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.33  (1.23) 4.17  (0.71) 4.23  (0.91)
[1]
Measure Description: 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.
OACIS-S sensory sensitivity score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.40  (0.74) 4.07  (0.65) 4.18  (0.69)
[1]
Measure Description: 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.
OACIS-S restricted interests score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 29 participants 44 participants
4.33  (0.72) 4.41  (0.63) 4.38  (0.65)
[1]
Measure Description: 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.
Hematology: Red Blood Cell (RBC) counts  
Mean (Standard Deviation)
Unit of measure:  *10^6 cells/µL
Number Analyzed 15 participants 29 participants 44 participants
5.1  (0.3) 5.2  (0.5) 5.2  (0.4)
Hematology: White Blood Cell (WBC) counts  
Mean (Standard Deviation)
Unit of measure:  *10^03 cells/µL
Number Analyzed 15 participants 29 participants 44 participants
6.9  (2.3) 6.8  (1.7) 6.8  (1.9)
Hematology: platelet counts  
Mean (Standard Deviation)
Unit of measure:  *10^03 cells/µL
Number Analyzed 15 participants 29 participants 44 participants
245.5  (47.8) 251.5  (55.5) 249.6  (52.6)
Blood chemistry: serum creatinine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 15 participants 29 participants 44 participants
0.8  (0.1) 0.8  (0.1) 0.8  (0.1)
Blood Chemistry: Serum glutamic oxaloacetic transaminase (SGOT)  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 15 participants 29 participants 44 participants
22.8  (6.4) 22.6  (8.6) 22.7  (7.9)
Blood Chemistry: Serum glutamic pyruvic transaminase (SGPT)  
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 15 participants 29 participants 44 participants
18.3  (6.1) 30.0  (20.6) 26.3  (18.1)
Blood chemistry: Thyroid Stimulating Hormone (TSH)  
Mean (Standard Deviation)
Unit of measure:  uIU/mL
Number Analyzed 15 participants 29 participants 44 participants
1.6  (0.9) 2.0  (2.1) 1.9  (1.8)
1.Primary Outcome
Title Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Hide Description

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.

Time Frame 4 weeks, 10 weeks, 18 weeks and 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from screening/baseline at 4 weeks -7.79  (3.09) -14.76  (3.79)
Change from screening/baseline at 10 weeks -1.38  (3.72) -14.48  (5.72)
Change from screening/baseline at 18 weeks -2.0  (3.46) -20.40  (4.54)
Change from screening/baseline at 22 weeks -6.67  (3.82) -7.03  (4.20)
2.Secondary Outcome
Title Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Hide Description

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.

Time Frame 4 weeks, 10 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change from screening/baseline at 4 weeks 0.77  (1.84) -12.69  (4.17)
Change from screening/baseline at 10 weeks 3.31  (3.50) -19.61  (5.95)
Change from screening/baseline at 18 weeks -2.0  (4.59) -21.44  (4.34)
Change from screening/baseline at 22 weeks -1.83  (6.60) -10.72  (5.07)
3.Secondary Outcome
Title Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Hide Description

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.

Time Frame 4 weeks, 10 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
OACIS-S general level of autism 4 weeks 4.36  (0.84) 4.38  (0.80)
OACIS-S general level of autism 10 weeks 4.43  (0.85) 4.31  (0.74)
OACIS-S general level of autism 18 weeks 4.50  (0.76) 4.42  (0.70)
OACIS-S general level of autism 22 weeks 4.70  (0.82) 4.50  (0.89)
OACIS-S social interaction 4 weeks 4.50  (1.16) 3.77  (0.99)
OACIS-S social interaction 10 weeks 4.57  (1.28) 3.46  (1.03)
OACIS-S social interaction 18 weeks 4.71  (1.27) 3.46  (1.14)
OACIS-S social interaction 22 weeks 5.0  (1.41) 4.60  (1.05)
OACIS-S aberrant behavior 4 weeks 4.36  (1.34) 3.73  (1.25)
OACIS-S aberrant behavior 10 weeks 4.29  (1.07) 3.27  (1.12)
OACIS-S aberrant behavior 18 weeks 4.43  (1.22) 3.19  (1.23)
OACIS-S aberrant behavior 22 weeks 4.90  (1.60) 4.35  (1.63)
OACIS-S repetitive behavior 4 weeks 3.86  (1.10) 4.08  (0.98)
OACIS-S repetitive behavior 10 weeks 4.14  (0.86) 3.62  (1.33)
OACIS-S repetitive behavior 18 weeks 4.14  (0.77) 3.69  (1.19)
OACIS-S repetitive behavior 22 weeks 4.30  (0.82) 4.55  (0.89)
OACIS-S verbal communication 4 weeks 4.43  (1.70) 3.73  (1.25)
OACIS-S verbal communication 10 weeks 4.21  (1.85) 3.73  (1.08)
OACIS-S verbal communication 18 weeks 4.71  (1.33) 3.54  (1.10)
OACIS-S verbal communication 22 weeks 5.20  (1.32) 4.80  (1.15)
OACIS-S non-verbal communication 4 weeks 4.29  (0.99) 3.85  (1.01)
OACIS-S non-verbal communication 10 weeks 4.23  (1.01) 3.73  (1.04)
OACIS-S non-verbal communication 18 weeks 4.43  (0.94) 3.69  (1.12)
OACIS-S non-verbal communication 22 weeks 4.40  (1.08) 4.25  (1.02)
OACIS-S hyperactivity 4 weeks 4.36  (1.01) 3.50  (1.14)
OACIS-S hyperactivity 10 weeks 4.07  (1.27) 3.54  (0.90)
OACIS-S hyperactivity 18 weeks 4.29  (1.07) 3.58  (1.17)
OACIS-S hyperactivity 22 weeks 4.20  (1.32) 4.25  (1.12)
OACIS-S anxiety 4 weeks 4.21  (0.89) 3.81  (0.98)
OACIS-S anxiety 10 weeks 4.43  (0.94) 3.69  (1.01)
OACIS-S anxiety 18 weeks 4.36  (1.01) 3.85  (1.01)
OACIS-S anxiety 22 weeks 4.50  (1.08) 4.20  (0.89)
OACIS-S sensory sensitivity 4 weeks 4.36  (0.50) 4.08  (0.74)
OACIS-S sensory sensitivity 10 weeks 4.43  (0.65) 4.00  (0.75)
OACIS-S sensory sensitivity 18 weeks 4.57  (0.51) 4.04  (1.00)
OACIS-S sensory sensitivity 22 weeks 4.60  (0.52) 4.20  (1.11)
OACIS-S restricted interests 4 weeks 4.07  (0.73) 4.27  (0.96)
OACIS-S restricted interests 10 weeks 4.00  (0.96) 3.92  (0.98)
OACIS-S restricted interests 18 weeks 4.21  (0.89) 3.92  (1.09)
OACIS-S restricted interests 22 weeks 4.50  (0.97) 4.55  (1.10)
4.Secondary Outcome
Title Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Hide Description

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.

Time Frame 4 weeks, 10 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
OACIS-I general level of autism 4 weeks 4.14  (0.53) 4.04  (0.20)
OACIS-I general level of autism 10 weeks 3.86  (0.36) 3.88  (0.33)
OACIS-I general level of autism 18 weeks 3.93  (0.27) 3.81  (0.40)
OACIS-I general level of autism 22 weeks 4.0  (0) 3.92  (0.27)
OACIS-I social interaction 4 weeks 3.71  (0.61) 3.38  (0.85)
OACIS-I social interaction 10 weeks 3.79  (0.58) 3.08  (0.89)
OACIS-I social interaction 18 weeks 3.92  (0.47) 3.08  (1.02)
OACIS-I social interaction 22 weeks 4.1  (0.32) 4.2  (0.77)
OACIS-I aberrant behavior 4 weeks 3.86  (0.66) 3.42  (0.99)
OACIS-I aberrant behavior 10 weeks 3.79  (0.58) 2.96  (1.0)
OACIS-I aberrant behavior 18 weeks 3.93  (0.73) 2.88  (0.99)
OACIS-I aberrant behavior 22 weeks 4.2  (0.64) 4.1  (1.12)
OACIS-I repetitive behavior 4 weeks 3.71  (0.61) 3.81  (0.57)
OACIS-I repetitive behavior 10 weeks 4  (0) 3.35  (0.89)
OACIS-I repetitive behavior 18 weeks 4  (0.39) 3.42  (0.86)
OACIS-I repetitive behavior 22 weeks 4.1  (0.32) 4.25  (0.55)
OACIS-I verbal communication 4 weeks 3.57  (0.76) 3.15  (0.92)
OACIS-I verbal communication 10 weeks 3.36  (0.84) 3.16  (0.83)
OACIS-I verbal communication 18 weeks 3.86  (0.53) 2.96  (0.92)
OACIS-I verbal communication 22 weeks 4  (0.47) 4.15  (0.59)
OACIS-I non-verbal communication 4 weeks 3.93  (0.27) 3.69  (0.62)
OACIS-I non-verbal communication 10 weeks 3.92  (0.28) 3.58  (0.76)
OACIS-I non-verbal communication 18 weeks 4.07  (0.27) 3.54  (0.764)
OACIS-I non-verbal communication 22 weeks 4  (0) 4  (0.46)
OACIS-I hyperactivity 4 weeks 4  (0) 3.42  (0.90)
OACIS-I hyperactivity 10 weeks 3.71  (0.61) 3.46  (0.81)
OACIS-I hyperactivity 18 weeks 3.93  (0.62) 3.5  (0.86)
OACIS-I hyperactivity 22 weeks 3.8  (0.42) 4.05  (0.69)
OACIS-I anxiety 4 weeks 4  (0) 3.65  (0.74)
OACIS-I anxiety 10 weeks 4.21  (0.43) 3.54  (0.81)
OACIS-I anxiety 18 weeks 4.14  (0.36) 3.69  (0.27)
OACIS-I anxiety 22 weeks 4.2  (0.42) 4  (0.46)
OACIS-I sensory sensitivity 4 weeks 3.86  (0.36) 3.85  (0.54)
OACIS-I sensory sensitivity 10 weeks 3.93  (0.27) 3.77  (0.51)
OACIS-I sensory sensitivity 18 weeks 4.07  (0.27) 3.81  (0.63)
OACIS-I sensory sensitivity 22 weeks 4  (0) 4  (0.65)
OACIS-I restricted interests 4 weeks 3.86  (0.53) 3.81  (0.49)
OACIS-I restricted interests 10 weeks 3.79  (0.43) 3.46  (0.71)
OACIS-I restricted interests 18 weeks 4  (0) 3.46  (0.86)
OACIS-I restricted interests 22 weeks 4.1  (0.32) 4.05  (0.83)
5.Secondary Outcome
Title Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks
Hide Description [Not Specified]
Time Frame 4 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: U/L
SGOT 4 weeks 27.6  (9.4) 23.8  (8.3)
SGOT 18 weeks 22.5  (9.2) 22.5  (5.4)
SGOT 22 weeks 21.8  (4.1) 25.4  (13.1)
SGPT 4 weeks 25.1  (16.8) 23.8  (8.3)
SGPT 18 weeks 22.2  (20.1) 31.1  (20.7)
SGPT 22 weeks 21  (10.4) 37.7  (33)
6.Secondary Outcome
Title Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks
Hide Description [Not Specified]
Time Frame 4 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: mg/dL
Serum Creatinine at 4 weeks 0.8  (0.1) 0.8  (0.1)
Serum Creatinine at 18 weeks 0.8  (0.1) 0.8  (0.1)
Serum Creatinine at 22 weeks 0.8  (0.1) 0.8  (0.1)
7.Secondary Outcome
Title Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks
Hide Description [Not Specified]
Time Frame 4 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: uIU/mL
TSH 4 weeks 1.8  (1.0) 1.8  (0.8)
TSH 18 weeks 1.5  (0.6) 1.9  (1.1)
TSH 22 weeks 1.2  (0.58) 1.7  (0.7)
8.Secondary Outcome
Title Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks
Hide Description [Not Specified]
Time Frame 4 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: *10^6 cells/µL
RBC count at 4 weeks 5.13  (0.36) 5.11  (0.36)
RBC count at 18 weeks 5.03  (0.38) 5.13  (0.40)
RBC count at 22 weeks 5.12  (0.37) 5.04  (0.38)
9.Secondary Outcome
Title White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks
Hide Description [Not Specified]
Time Frame 4 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: *10^3 cells/µL
WBC count at 4 weeks 6.63  (1.91) 6.32  (1.56)
WBC count at 18 weeks 6.33  (1.71) 5.94  (1.63)
WBC count at 22 weeks 6.12  (1.45) 6.18  (1.84)
10.Secondary Outcome
Title Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks
Hide Description [Not Specified]
Time Frame 4 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: *10^3 cells/µL
Platelet count at 4 weeks 242.1  (48.1) 235.0  (38.3)
Platelet count at 18 weeks 236.8  (44.8) 237.1  (45.2)
Platelet count at 22 weeks 218.1  (49.2) 255.0  (52.2)
11.Secondary Outcome
Title 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
Hide Description *Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported.
Time Frame Screening, baseline, 24 hours after first dose of study medication, 4 weeks, 10 weeks, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
*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.
Arm/Group Title Placebo Interventional
Hide Arm/Group Description:
Inactive placebo.
Sulforaphane-rich Broccoli Sprout Extract.
Overall Number of Participants Analyzed 13 26
Mean (Standard Deviation)
Unit of Measure: pG/mL
0.007  (0.11) 0.017  (0.09)
12.Secondary Outcome
Title 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
Hide Description Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported.
Time Frame Screening, 24 hours after first dose of study medication, 18 weeks, 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Interventional
Hide Arm/Group Description:
Inactive placebo.
Sulforaphane-rich Broccoli Sprout Extract.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: fold change
-0.116  (0.037) -0.0008  (0.014)
Time Frame 22 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Sulforaphane-rich Broccoli Sprout Extract
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Placebo Sulforaphane-rich Broccoli Sprout Extract
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Placebo Sulforaphane-rich Broccoli Sprout Extract
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/26 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Sulforaphane-rich Broccoli Sprout Extract
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/14 (28.57%)      5/26 (19.23%)    
Gastrointestinal disorders     
Vomiting   1/14 (7.14%)  5/26 (19.23%) 
Abdominal pain   2/14 (14.29%)  4/26 (15.38%) 
Increased Flatulence   2/14 (14.29%)  4/26 (15.38%) 
Constipation   2/14 (14.29%)  3/26 (11.54%) 
Diarrhea   1/14 (7.14%)  3/26 (11.54%) 
Increased burping   3/14 (21.43%)  0/26 (0.00%) 
General disorders     
Fever   1/14 (7.14%)  3/26 (11.54%) 
Seasonal allergy exacerbation   0/14 (0.00%)  3/26 (11.54%) 
Insomnia   4/14 (28.57%)  2/26 (7.69%) 
Increased appetite   1/14 (7.14%)  1/26 (3.85%) 
Investigations     
Abnormal platelet count   1/14 (7.14%)  1/26 (3.85%) 
Abnormal WBC count   1/14 (7.14%)  2/26 (7.69%) 
SGPT outside of reference range   1/14 (7.14%)  4/26 (15.38%) 
SGOT outside of reference range   1/14 (7.14%)  0/26 (0.00%) 
TSH outside of reference range   1/14 (7.14%)  1/26 (3.85%) 
Nervous system disorders     
Headache   1/14 (7.14%)  3/26 (11.54%) 
Seizures   0/14 (0.00%)  0 2/26 (7.69%)  2
Psychiatric disorders     
Increased aggressions   2/14 (14.29%)  4/26 (15.38%) 
Increased irritability   0/14 (0.00%)  3/26 (11.54%) 
Increased stubbornness   0/14 (0.00%)  2/26 (7.69%) 
Increased agitation   1/14 (7.14%)  1/26 (3.85%) 
Crying spells   1/14 (7.14%)  1/26 (3.85%) 
Hyperactivity   2/14 (14.29%)  1/26 (3.85%) 
Increased anxiety   2/14 (14.29%)  0/26 (0.00%) 
Lethargy   2/14 (14.29%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough   0/14 (0.00%)  2/26 (7.69%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Zimmerman, M.D.
Organization: UMass Medical School
Phone: 508-856-3279
EMail: Andrew.Zimmerman@umassmemorial.org
Layout table for additonal information
Responsible Party: Andrew Zimmerman, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01474993    
Other Study ID Numbers: 2011P002221
First Submitted: November 8, 2011
First Posted: November 18, 2011
Results First Submitted: November 4, 2014
Results First Posted: November 24, 2014
Last Update Posted: September 12, 2018