Trial Outcomes & Findings for Sulforaphane-rich Broccoli Sprout Extract for Autism (NCT NCT01474993)
NCT ID: NCT01474993
Last Updated: 2018-09-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
4 weeks, 10 weeks, 18 weeks and 22 weeks
Results posted on
2018-09-12
Participant Flow
Forty-four study participants were initially enrolled in the study from January 2011 to July 2013 at Lurie Center for Autism.
Participant milestones
| Measure |
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.
|
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:
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)
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
29
|
|
Overall Study
COMPLETED
|
14
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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:
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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Sulforaphane-rich Broccoli Sprout Extract for Autism
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
15 participants were randomized to placebo.
|
Sulforaphane-rich Broccoli Sprout Extract
n=29 Participants
29 subjects were randomized to receive sulforaphane.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.6 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
17.9 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
17.4 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
29 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Aberrant Behavior Checklist total score
|
60 units on a scale
STANDARD_DEVIATION 23.2 • n=5 Participants
|
63.6 units on a scale
STANDARD_DEVIATION 25.3 • n=7 Participants
|
62.3 units on a scale
STANDARD_DEVIATION 24.4 • n=5 Participants
|
|
Social Responsiveness Scale total score
|
120.1 units on a scale
STANDARD_DEVIATION 16.6 • n=5 Participants
|
122.2 units on a scale
STANDARD_DEVIATION 24.1 • n=7 Participants
|
121.5 units on a scale
STANDARD_DEVIATION 21.6 • n=5 Participants
|
|
OACIS-S general level of autism score
|
4.53 units on a scale
STANDARD_DEVIATION 0.74 • n=5 Participants
|
4.38 units on a scale
STANDARD_DEVIATION 0.56 • n=7 Participants
|
4.43 units on a scale
STANDARD_DEVIATION 0.62 • n=5 Participants
|
|
OACIS-S social interaction score
|
4.80 units on a scale
STANDARD_DEVIATION 1.01 • n=5 Participants
|
4.51 units on a scale
STANDARD_DEVIATION 0.69 • n=7 Participants
|
4.61 units on a scale
STANDARD_DEVIATION 0.81 • n=5 Participants
|
|
OACIS-S aberrant behavior score
|
4.20 units on a scale
STANDARD_DEVIATION 1.37 • n=5 Participants
|
4.21 units on a scale
STANDARD_DEVIATION 0.86 • n=7 Participants
|
4.20 units on a scale
STANDARD_DEVIATION 1.05 • n=5 Participants
|
|
Hematology: Red Blood Cell (RBC) counts
|
5.1 *10^6 cells/µL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
5.2 *10^6 cells/µL
STANDARD_DEVIATION 0.5 • n=7 Participants
|
5.2 *10^6 cells/µL
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
OACIS-S repetitive behavior score
|
4.13 units on a scale
STANDARD_DEVIATION 0.83 • n=5 Participants
|
4.14 units on a scale
STANDARD_DEVIATION 0.74 • n=7 Participants
|
4.13 units on a scale
STANDARD_DEVIATION 0.77 • n=5 Participants
|
|
OACIS-S verbal communication score
|
4.53 units on a scale
STANDARD_DEVIATION 1.36 • n=5 Participants
|
4.45 units on a scale
STANDARD_DEVIATION 0.95 • n=7 Participants
|
4.48 units on a scale
STANDARD_DEVIATION 1.09 • n=5 Participants
|
|
OACIS-S nonverbal communication score
|
4.27 units on a scale
STANDARD_DEVIATION 0.96 • n=5 Participants
|
4.10 units on a scale
STANDARD_DEVIATION 0.72 • n=7 Participants
|
4.16 units on a scale
STANDARD_DEVIATION 0.81 • n=5 Participants
|
|
OACIS-S hyperactivity/inattention score
|
4.40 units on a scale
STANDARD_DEVIATION 0.91 • n=5 Participants
|
4.10 units on a scale
STANDARD_DEVIATION 0.90 • n=7 Participants
|
4.20 units on a scale
STANDARD_DEVIATION 0.90 • n=5 Participants
|
|
OACIS-S anxiety score
|
4.33 units on a scale
STANDARD_DEVIATION 1.23 • n=5 Participants
|
4.17 units on a scale
STANDARD_DEVIATION 0.71 • n=7 Participants
|
4.23 units on a scale
STANDARD_DEVIATION 0.91 • n=5 Participants
|
|
OACIS-S sensory sensitivity score
|
4.40 units on a scale
STANDARD_DEVIATION 0.74 • n=5 Participants
|
4.07 units on a scale
STANDARD_DEVIATION 0.65 • n=7 Participants
|
4.18 units on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants
|
|
OACIS-S restricted interests score
|
4.33 units on a scale
STANDARD_DEVIATION 0.72 • n=5 Participants
|
4.41 units on a scale
STANDARD_DEVIATION 0.63 • n=7 Participants
|
4.38 units on a scale
STANDARD_DEVIATION 0.65 • n=5 Participants
|
|
Hematology: White Blood Cell (WBC) counts
|
6.9 *10^03 cells/µL
STANDARD_DEVIATION 2.3 • n=5 Participants
|
6.8 *10^03 cells/µL
STANDARD_DEVIATION 1.7 • n=7 Participants
|
6.8 *10^03 cells/µL
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Hematology: platelet counts
|
245.5 *10^03 cells/µL
STANDARD_DEVIATION 47.8 • n=5 Participants
|
251.5 *10^03 cells/µL
STANDARD_DEVIATION 55.5 • n=7 Participants
|
249.6 *10^03 cells/µL
STANDARD_DEVIATION 52.6 • n=5 Participants
|
|
Blood chemistry: serum creatinine
|
0.8 mg/dL
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 0.1 • n=7 Participants
|
0.8 mg/dL
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Blood Chemistry: Serum glutamic oxaloacetic transaminase (SGOT)
|
22.8 U/L
STANDARD_DEVIATION 6.4 • n=5 Participants
|
22.6 U/L
STANDARD_DEVIATION 8.6 • n=7 Participants
|
22.7 U/L
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Blood Chemistry: Serum glutamic pyruvic transaminase (SGPT)
|
18.3 U/L
STANDARD_DEVIATION 6.1 • n=5 Participants
|
30.0 U/L
STANDARD_DEVIATION 20.6 • n=7 Participants
|
26.3 U/L
STANDARD_DEVIATION 18.1 • n=5 Participants
|
|
Blood chemistry: Thyroid Stimulating Hormone (TSH)
|
1.6 uIU/mL
STANDARD_DEVIATION 0.9 • n=5 Participants
|
2.0 uIU/mL
STANDARD_DEVIATION 2.1 • n=7 Participants
|
1.9 uIU/mL
STANDARD_DEVIATION 1.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks, 10 weeks, 18 weeks and 22 weeksThe 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.
Outcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Change from screening/baseline at 4 weeks
|
-7.79 units on a scale
Standard Deviation 3.09
|
-14.76 units on a scale
Standard Deviation 3.79
|
|
Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Change from screening/baseline at 10 weeks
|
-1.38 units on a scale
Standard Deviation 3.72
|
-14.48 units on a scale
Standard Deviation 5.72
|
|
Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Change from screening/baseline at 18 weeks
|
-2.0 units on a scale
Standard Deviation 3.46
|
-20.40 units on a scale
Standard Deviation 4.54
|
|
Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Change from screening/baseline at 22 weeks
|
-6.67 units on a scale
Standard Deviation 3.82
|
-7.03 units on a scale
Standard Deviation 4.20
|
SECONDARY outcome
Timeframe: 4 weeks, 10 weeks, 18 weeks, 22 weeksThe 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.
Outcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Change from screening/baseline at 4 weeks
|
0.77 units on a scale
Standard Deviation 1.84
|
-12.69 units on a scale
Standard Deviation 4.17
|
|
Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Change from screening/baseline at 10 weeks
|
3.31 units on a scale
Standard Deviation 3.50
|
-19.61 units on a scale
Standard Deviation 5.95
|
|
Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Change from screening/baseline at 18 weeks
|
-2.0 units on a scale
Standard Deviation 4.59
|
-21.44 units on a scale
Standard Deviation 4.34
|
|
Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
Change from screening/baseline at 22 weeks
|
-1.83 units on a scale
Standard Deviation 6.60
|
-10.72 units on a scale
Standard Deviation 5.07
|
SECONDARY outcome
Timeframe: 4 weeks, 10 weeks, 18 weeks, 22 weeksOACIS-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.
Outcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S general level of autism 4 weeks
|
4.36 units on a scale
Standard Deviation 0.84
|
4.38 units on a scale
Standard Deviation 0.80
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S general level of autism 10 weeks
|
4.43 units on a scale
Standard Deviation 0.85
|
4.31 units on a scale
Standard Deviation 0.74
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S general level of autism 18 weeks
|
4.50 units on a scale
Standard Deviation 0.76
|
4.42 units on a scale
Standard Deviation 0.70
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S general level of autism 22 weeks
|
4.70 units on a scale
Standard Deviation 0.82
|
4.50 units on a scale
Standard Deviation 0.89
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S social interaction 4 weeks
|
4.50 units on a scale
Standard Deviation 1.16
|
3.77 units on a scale
Standard Deviation 0.99
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S social interaction 10 weeks
|
4.57 units on a scale
Standard Deviation 1.28
|
3.46 units on a scale
Standard Deviation 1.03
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S social interaction 18 weeks
|
4.71 units on a scale
Standard Deviation 1.27
|
3.46 units on a scale
Standard Deviation 1.14
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S social interaction 22 weeks
|
5.0 units on a scale
Standard Deviation 1.41
|
4.60 units on a scale
Standard Deviation 1.05
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S aberrant behavior 4 weeks
|
4.36 units on a scale
Standard Deviation 1.34
|
3.73 units on a scale
Standard Deviation 1.25
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S aberrant behavior 10 weeks
|
4.29 units on a scale
Standard Deviation 1.07
|
3.27 units on a scale
Standard Deviation 1.12
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S aberrant behavior 18 weeks
|
4.43 units on a scale
Standard Deviation 1.22
|
3.19 units on a scale
Standard Deviation 1.23
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S aberrant behavior 22 weeks
|
4.90 units on a scale
Standard Deviation 1.60
|
4.35 units on a scale
Standard Deviation 1.63
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S repetitive behavior 4 weeks
|
3.86 units on a scale
Standard Deviation 1.10
|
4.08 units on a scale
Standard Deviation 0.98
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S repetitive behavior 10 weeks
|
4.14 units on a scale
Standard Deviation 0.86
|
3.62 units on a scale
Standard Deviation 1.33
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S repetitive behavior 18 weeks
|
4.14 units on a scale
Standard Deviation 0.77
|
3.69 units on a scale
Standard Deviation 1.19
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S verbal communication 4 weeks
|
4.43 units on a scale
Standard Deviation 1.70
|
3.73 units on a scale
Standard Deviation 1.25
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S verbal communication 10 weeks
|
4.21 units on a scale
Standard Deviation 1.85
|
3.73 units on a scale
Standard Deviation 1.08
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S verbal communication 18 weeks
|
4.71 units on a scale
Standard Deviation 1.33
|
3.54 units on a scale
Standard Deviation 1.10
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S non-verbal communication 4 weeks
|
4.29 units on a scale
Standard Deviation 0.99
|
3.85 units on a scale
Standard Deviation 1.01
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S non-verbal communication 10 weeks
|
4.23 units on a scale
Standard Deviation 1.01
|
3.73 units on a scale
Standard Deviation 1.04
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S non-verbal communication 18 weeks
|
4.43 units on a scale
Standard Deviation 0.94
|
3.69 units on a scale
Standard Deviation 1.12
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S non-verbal communication 22 weeks
|
4.40 units on a scale
Standard Deviation 1.08
|
4.25 units on a scale
Standard Deviation 1.02
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S hyperactivity 4 weeks
|
4.36 units on a scale
Standard Deviation 1.01
|
3.50 units on a scale
Standard Deviation 1.14
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S hyperactivity 10 weeks
|
4.07 units on a scale
Standard Deviation 1.27
|
3.54 units on a scale
Standard Deviation 0.90
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S hyperactivity 18 weeks
|
4.29 units on a scale
Standard Deviation 1.07
|
3.58 units on a scale
Standard Deviation 1.17
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S hyperactivity 22 weeks
|
4.20 units on a scale
Standard Deviation 1.32
|
4.25 units on a scale
Standard Deviation 1.12
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S anxiety 4 weeks
|
4.21 units on a scale
Standard Deviation 0.89
|
3.81 units on a scale
Standard Deviation 0.98
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S anxiety 10 weeks
|
4.43 units on a scale
Standard Deviation 0.94
|
3.69 units on a scale
Standard Deviation 1.01
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S anxiety 18 weeks
|
4.36 units on a scale
Standard Deviation 1.01
|
3.85 units on a scale
Standard Deviation 1.01
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S anxiety 22 weeks
|
4.50 units on a scale
Standard Deviation 1.08
|
4.20 units on a scale
Standard Deviation 0.89
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S sensory sensitivity 4 weeks
|
4.36 units on a scale
Standard Deviation 0.50
|
4.08 units on a scale
Standard Deviation 0.74
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S sensory sensitivity 10 weeks
|
4.43 units on a scale
Standard Deviation 0.65
|
4.00 units on a scale
Standard Deviation 0.75
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S sensory sensitivity 18 weeks
|
4.57 units on a scale
Standard Deviation 0.51
|
4.04 units on a scale
Standard Deviation 1.00
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S sensory sensitivity 22 weeks
|
4.60 units on a scale
Standard Deviation 0.52
|
4.20 units on a scale
Standard Deviation 1.11
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S restricted interests 4 weeks
|
4.07 units on a scale
Standard Deviation 0.73
|
4.27 units on a scale
Standard Deviation 0.96
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S restricted interests 10 weeks
|
4.00 units on a scale
Standard Deviation 0.96
|
3.92 units on a scale
Standard Deviation 0.98
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S restricted interests 18 weeks
|
4.21 units on a scale
Standard Deviation 0.89
|
3.92 units on a scale
Standard Deviation 1.09
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S restricted interests 22 weeks
|
4.50 units on a scale
Standard Deviation 0.97
|
4.55 units on a scale
Standard Deviation 1.10
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S repetitive behavior 22 weeks
|
4.30 units on a scale
Standard Deviation 0.82
|
4.55 units on a scale
Standard Deviation 0.89
|
|
Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-S verbal communication 22 weeks
|
5.20 units on a scale
Standard Deviation 1.32
|
4.80 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 4 weeks, 10 weeks, 18 weeks, 22 weeksThe 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.
Outcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I general level of autism 4 weeks
|
4.14 units on a scale
Standard Deviation 0.53
|
4.04 units on a scale
Standard Deviation 0.20
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I general level of autism 18 weeks
|
3.93 units on a scale
Standard Deviation 0.27
|
3.81 units on a scale
Standard Deviation 0.40
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I general level of autism 22 weeks
|
4.0 units on a scale
Standard Deviation 0
|
3.92 units on a scale
Standard Deviation 0.27
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I social interaction 4 weeks
|
3.71 units on a scale
Standard Deviation 0.61
|
3.38 units on a scale
Standard Deviation 0.85
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I social interaction 10 weeks
|
3.79 units on a scale
Standard Deviation 0.58
|
3.08 units on a scale
Standard Deviation 0.89
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I social interaction 18 weeks
|
3.92 units on a scale
Standard Deviation 0.47
|
3.08 units on a scale
Standard Deviation 1.02
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I social interaction 22 weeks
|
4.1 units on a scale
Standard Deviation 0.32
|
4.2 units on a scale
Standard Deviation 0.77
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I aberrant behavior 4 weeks
|
3.86 units on a scale
Standard Deviation 0.66
|
3.42 units on a scale
Standard Deviation 0.99
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I aberrant behavior 10 weeks
|
3.79 units on a scale
Standard Deviation 0.58
|
2.96 units on a scale
Standard Deviation 1.0
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I aberrant behavior 18 weeks
|
3.93 units on a scale
Standard Deviation 0.73
|
2.88 units on a scale
Standard Deviation 0.99
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I aberrant behavior 22 weeks
|
4.2 units on a scale
Standard Deviation 0.64
|
4.1 units on a scale
Standard Deviation 1.12
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I repetitive behavior 4 weeks
|
3.71 units on a scale
Standard Deviation 0.61
|
3.81 units on a scale
Standard Deviation 0.57
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I repetitive behavior 10 weeks
|
4 units on a scale
Standard Deviation 0
|
3.35 units on a scale
Standard Deviation 0.89
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I repetitive behavior 18 weeks
|
4 units on a scale
Standard Deviation 0.39
|
3.42 units on a scale
Standard Deviation 0.86
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I repetitive behavior 22 weeks
|
4.1 units on a scale
Standard Deviation 0.32
|
4.25 units on a scale
Standard Deviation 0.55
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I verbal communication 4 weeks
|
3.57 units on a scale
Standard Deviation 0.76
|
3.15 units on a scale
Standard Deviation 0.92
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I verbal communication 10 weeks
|
3.36 units on a scale
Standard Deviation 0.84
|
3.16 units on a scale
Standard Deviation 0.83
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I verbal communication 18 weeks
|
3.86 units on a scale
Standard Deviation 0.53
|
2.96 units on a scale
Standard Deviation 0.92
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I non-verbal communication 18 weeks
|
4.07 units on a scale
Standard Deviation 0.27
|
3.54 units on a scale
Standard Deviation 0.764
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I anxiety 22 weeks
|
4.2 units on a scale
Standard Deviation 0.42
|
4 units on a scale
Standard Deviation 0.46
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I sensory sensitivity 22 weeks
|
4 units on a scale
Standard Deviation 0
|
4 units on a scale
Standard Deviation 0.65
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I restricted interests 4 weeks
|
3.86 units on a scale
Standard Deviation 0.53
|
3.81 units on a scale
Standard Deviation 0.49
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I restricted interests 18 weeks
|
4 units on a scale
Standard Deviation 0
|
3.46 units on a scale
Standard Deviation 0.86
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I hyperactivity 10 weeks
|
3.71 units on a scale
Standard Deviation 0.61
|
3.46 units on a scale
Standard Deviation 0.81
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I general level of autism 10 weeks
|
3.86 units on a scale
Standard Deviation 0.36
|
3.88 units on a scale
Standard Deviation 0.33
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I verbal communication 22 weeks
|
4 units on a scale
Standard Deviation 0.47
|
4.15 units on a scale
Standard Deviation 0.59
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I non-verbal communication 4 weeks
|
3.93 units on a scale
Standard Deviation 0.27
|
3.69 units on a scale
Standard Deviation 0.62
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I non-verbal communication 10 weeks
|
3.92 units on a scale
Standard Deviation 0.28
|
3.58 units on a scale
Standard Deviation 0.76
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I non-verbal communication 22 weeks
|
4 units on a scale
Standard Deviation 0
|
4 units on a scale
Standard Deviation 0.46
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I hyperactivity 4 weeks
|
4 units on a scale
Standard Deviation 0
|
3.42 units on a scale
Standard Deviation 0.90
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I hyperactivity 18 weeks
|
3.93 units on a scale
Standard Deviation 0.62
|
3.5 units on a scale
Standard Deviation 0.86
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I hyperactivity 22 weeks
|
3.8 units on a scale
Standard Deviation 0.42
|
4.05 units on a scale
Standard Deviation 0.69
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I anxiety 4 weeks
|
4 units on a scale
Standard Deviation 0
|
3.65 units on a scale
Standard Deviation 0.74
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I anxiety 10 weeks
|
4.21 units on a scale
Standard Deviation 0.43
|
3.54 units on a scale
Standard Deviation 0.81
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I anxiety 18 weeks
|
4.14 units on a scale
Standard Deviation 0.36
|
3.69 units on a scale
Standard Deviation 0.27
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I sensory sensitivity 4 weeks
|
3.86 units on a scale
Standard Deviation 0.36
|
3.85 units on a scale
Standard Deviation 0.54
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I sensory sensitivity 10 weeks
|
3.93 units on a scale
Standard Deviation 0.27
|
3.77 units on a scale
Standard Deviation 0.51
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I sensory sensitivity 18 weeks
|
4.07 units on a scale
Standard Deviation 0.27
|
3.81 units on a scale
Standard Deviation 0.63
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I restricted interests 10 weeks
|
3.79 units on a scale
Standard Deviation 0.43
|
3.46 units on a scale
Standard Deviation 0.71
|
|
Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
OACIS-I restricted interests 22 weeks
|
4.1 units on a scale
Standard Deviation 0.32
|
4.05 units on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 4 weeks, 18 weeks, 22 weeksOutcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks
SGOT 4 weeks
|
27.6 U/L
Standard Deviation 9.4
|
23.8 U/L
Standard Deviation 8.3
|
|
Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks
SGOT 18 weeks
|
22.5 U/L
Standard Deviation 9.2
|
22.5 U/L
Standard Deviation 5.4
|
|
Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks
SGOT 22 weeks
|
21.8 U/L
Standard Deviation 4.1
|
25.4 U/L
Standard Deviation 13.1
|
|
Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks
SGPT 4 weeks
|
25.1 U/L
Standard Deviation 16.8
|
23.8 U/L
Standard Deviation 8.3
|
|
Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks
SGPT 18 weeks
|
22.2 U/L
Standard Deviation 20.1
|
31.1 U/L
Standard Deviation 20.7
|
|
Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks
SGPT 22 weeks
|
21 U/L
Standard Deviation 10.4
|
37.7 U/L
Standard Deviation 33
|
SECONDARY outcome
Timeframe: 4 weeks, 18 weeks, 22 weeksOutcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks
Serum Creatinine at 4 weeks
|
0.8 mg/dL
Standard Deviation 0.1
|
0.8 mg/dL
Standard Deviation 0.1
|
|
Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks
Serum Creatinine at 18 weeks
|
0.8 mg/dL
Standard Deviation 0.1
|
0.8 mg/dL
Standard Deviation 0.1
|
|
Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks
Serum Creatinine at 22 weeks
|
0.8 mg/dL
Standard Deviation 0.1
|
0.8 mg/dL
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 4 weeks, 18 weeks, 22 weeksOutcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks
TSH 4 weeks
|
1.8 uIU/mL
Standard Deviation 1.0
|
1.8 uIU/mL
Standard Deviation 0.8
|
|
Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks
TSH 18 weeks
|
1.5 uIU/mL
Standard Deviation 0.6
|
1.9 uIU/mL
Standard Deviation 1.1
|
|
Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks
TSH 22 weeks
|
1.2 uIU/mL
Standard Deviation 0.58
|
1.7 uIU/mL
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 4 weeks, 18 weeks, 22 weeksOutcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks
RBC count at 4 weeks
|
5.13 *10^6 cells/µL
Standard Deviation 0.36
|
5.11 *10^6 cells/µL
Standard Deviation 0.36
|
|
Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks
RBC count at 18 weeks
|
5.03 *10^6 cells/µL
Standard Deviation 0.38
|
5.13 *10^6 cells/µL
Standard Deviation 0.40
|
|
Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks
RBC count at 22 weeks
|
5.12 *10^6 cells/µL
Standard Deviation 0.37
|
5.04 *10^6 cells/µL
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: 4 weeks, 18 weeks, 22 weeksOutcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks
WBC count at 4 weeks
|
6.63 *10^3 cells/µL
Standard Deviation 1.91
|
6.32 *10^3 cells/µL
Standard Deviation 1.56
|
|
White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks
WBC count at 18 weeks
|
6.33 *10^3 cells/µL
Standard Deviation 1.71
|
5.94 *10^3 cells/µL
Standard Deviation 1.63
|
|
White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks
WBC count at 22 weeks
|
6.12 *10^3 cells/µL
Standard Deviation 1.45
|
6.18 *10^3 cells/µL
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: 4 weeks, 18 weeks, 22 weeksOutcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks
Platelet count at 4 weeks
|
242.1 *10^3 cells/µL
Standard Deviation 48.1
|
235.0 *10^3 cells/µL
Standard Deviation 38.3
|
|
Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks
Platelet count at 18 weeks
|
236.8 *10^3 cells/µL
Standard Deviation 44.8
|
237.1 *10^3 cells/µL
Standard Deviation 45.2
|
|
Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks
Platelet count at 22 weeks
|
218.1 *10^3 cells/µL
Standard Deviation 49.2
|
255.0 *10^3 cells/µL
Standard Deviation 52.2
|
SECONDARY outcome
Timeframe: Screening, baseline, 24 hours after first dose of study medication, 4 weeks, 10 weeks, 18 weeks, 22 weeksPopulation: \*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.
\*Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported.
Outcome measures
| Measure |
Placebo
n=13 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Change From Screening and Baseline in Urinary Isoprostane F2α-VI Levels at 24 Hours After First Dose, at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks
|
0.007 pG/mL
Standard Deviation 0.11
|
0.017 pG/mL
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Screening, 24 hours after first dose of study medication, 18 weeks, 22 weeksDue to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported.
Outcome measures
| Measure |
Placebo
n=14 Participants
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 Participants
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.
|
|---|---|---|
|
Change From the Screening Visit in Heat Shock Protein Gene Expression (Relative Maximum Gene Expression) at 24 Hours After First Dose, 18 Weeks and 22 Weeks
|
-0.116 fold change
Standard Deviation 0.037
|
-0.0008 fold change
Standard Deviation 0.014
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sulforaphane-rich Broccoli Sprout Extract
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=14 participants at risk
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.
|
Sulforaphane-rich Broccoli Sprout Extract
n=26 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • 22 weeks
|
19.2%
5/26 • 22 weeks
|
|
Psychiatric disorders
Increased aggressions
|
14.3%
2/14 • 22 weeks
|
15.4%
4/26 • 22 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
2/14 • 22 weeks
|
15.4%
4/26 • 22 weeks
|
|
Gastrointestinal disorders
Increased Flatulence
|
14.3%
2/14 • 22 weeks
|
15.4%
4/26 • 22 weeks
|
|
Psychiatric disorders
Increased irritability
|
0.00%
0/14 • 22 weeks
|
11.5%
3/26 • 22 weeks
|
|
Gastrointestinal disorders
Constipation
|
14.3%
2/14 • 22 weeks
|
11.5%
3/26 • 22 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • 22 weeks
|
11.5%
3/26 • 22 weeks
|
|
General disorders
Fever
|
7.1%
1/14 • 22 weeks
|
11.5%
3/26 • 22 weeks
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • 22 weeks
|
11.5%
3/26 • 22 weeks
|
|
General disorders
Seasonal allergy exacerbation
|
0.00%
0/14 • 22 weeks
|
11.5%
3/26 • 22 weeks
|
|
Nervous system disorders
Seizures
|
0.00%
0/14 • 22 weeks
|
7.7%
2/26 • Number of events 2 • 22 weeks
|
|
Psychiatric disorders
Increased stubbornness
|
0.00%
0/14 • 22 weeks
|
7.7%
2/26 • 22 weeks
|
|
General disorders
Insomnia
|
28.6%
4/14 • 22 weeks
|
7.7%
2/26 • 22 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • 22 weeks
|
7.7%
2/26 • 22 weeks
|
|
Psychiatric disorders
Increased agitation
|
7.1%
1/14 • 22 weeks
|
3.8%
1/26 • 22 weeks
|
|
Psychiatric disorders
Crying spells
|
7.1%
1/14 • 22 weeks
|
3.8%
1/26 • 22 weeks
|
|
Psychiatric disorders
Hyperactivity
|
14.3%
2/14 • 22 weeks
|
3.8%
1/26 • 22 weeks
|
|
General disorders
Increased appetite
|
7.1%
1/14 • 22 weeks
|
3.8%
1/26 • 22 weeks
|
|
Psychiatric disorders
Increased anxiety
|
14.3%
2/14 • 22 weeks
|
0.00%
0/26 • 22 weeks
|
|
Psychiatric disorders
Lethargy
|
14.3%
2/14 • 22 weeks
|
0.00%
0/26 • 22 weeks
|
|
Gastrointestinal disorders
Increased burping
|
21.4%
3/14 • 22 weeks
|
0.00%
0/26 • 22 weeks
|
|
Investigations
Abnormal platelet count
|
7.1%
1/14 • 22 weeks
|
3.8%
1/26 • 22 weeks
|
|
Investigations
Abnormal WBC count
|
7.1%
1/14 • 22 weeks
|
7.7%
2/26 • 22 weeks
|
|
Investigations
SGPT outside of reference range
|
7.1%
1/14 • 22 weeks
|
15.4%
4/26 • 22 weeks
|
|
Investigations
SGOT outside of reference range
|
7.1%
1/14 • 22 weeks
|
0.00%
0/26 • 22 weeks
|
|
Investigations
TSH outside of reference range
|
7.1%
1/14 • 22 weeks
|
3.8%
1/26 • 22 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place