Trial · NCT02909959
Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder
NCT02909959, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2020-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder. Trials, record NCT02909959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02909959
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sulforaphane for the Treatment of Young Men With Autism Spectrum Disorder
- NCT number
- NCT02909959
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Autism Spectrum Disorder, Autistic Disorder, Neurodevelopmental Disorder, Childhood Developmental Disorders, Pervasive
- Interventions
- Sulforaphane, Placebo
- First posted
- 2016-09-21
- Last updated
- 2020-06-04
- Results first posted
- 2020-05-15
Source ClinicalTrials.gov
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Social Responsiveness Scale-2 (SRS-2) Total Score at Baseline | Baseline | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90. |
| Primary | Social Responsiveness Scale-2 (SRS-2) Total Score at Week 4 | Week 4 | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90. |
| Primary | Social Responsiveness Scale-2 (SRS-2) Total Score at Week 8 | Week 8 | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90. |
| Primary | Social Responsiveness Scale-2 (SRS-2) Total Score at Week 12 | Week 12 | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90. |
| Primary | Social Responsiveness Scale-2 (SRS-2) Total Score at Week 16 | Week 16 | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2 provides a T-score that is scaled such that the mean is 50 and the SD is 10. Higher scores indicate a higher presence and severity of autistic social impairment. A T-score of 76 or higher is considered "severe". T-scores between 66 and 75 are considered as "moderate". T-scores between 60 and 65 are considered "mild". A T-score below 60 is considered typical. The theoretical range of a T-score is 10 to 90. The actual range of the SRS-2 in this study is 45 to 90. |
| Secondary | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness) | Baseline, Week 4, Week 8, Week 12, Week 16 | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Awareness subscale measures a participant's ability to recognize social cues. This subscale comprises 8 items with scores ranging from 1 to 4 for a total range of scores from 8 to 32. A higher score represents a greater ability to recognize social cues. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16. |
| Secondary | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition) | Baseline, Week 4, Week 8, Week 12, Week 16 | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Cognition subscale measures a participant's ability to interpret social behavior. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater ability to interpret social behaviors. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16. |
| Secondary | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication) | Baseline, Week 4, Week 8, Week 12, Week 16 | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Communication subscale measures a participant's ability to assess reciprocal communication in social situations. This subscale comprises 22 items with scores ranging from 1 to 4 for a total range of scores from 22 to 88. A higher score represents a greater ability to assess reciprocal communication. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16. |
| Secondary | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation) | Baseline, Week 4, Week 8, Week 12, Week 16 | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Social Motivation subscale measures the degree to which a participant is motivated to participate in social interactions. This subscale comprises 11 items with scores ranging from 1 to 4 for a total range of scores from 11 to 44. A higher score represents a greater motivation to participate in social interaction. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16. |
| Secondary | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors) | Baseline, Week 4, Week 8, Week 12, Week 16 | The Social Responsiveness Scale-2 (SRS-2) is a 65-item caregiver report that includes 5 subscales covering core symptom domains of ASD (Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests/ Repetitive Behaviors). The SRS-2-Restricted Interests/Repetitive Behaviors subscale assesses the participant's level of stereotypy and circumscribed interests. This subscale comprises 12 items with scores ranging from 1 to 4 for a total range of scores from 12 to 48. A higher score represents a greater level of stereotypy and circumscribed interests. Subscales are not diagnostic in nature, but they provide some insight into individual behaviors. This subscale was measured at Baseline, Week 4, Week 8, Week 12, and Week 16. |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 registered outcomesOutcomes47
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Social Responsiveness Scale-2 (SRS-2) Total Score at Baseline | Baseline | T-score | LEAST_SQUARES_MEAN | |
| PRIMARY | Social Responsiveness Scale-2 (SRS-2) Total Score at Week 4 | Week 4 | T-score | LEAST_SQUARES_MEAN | |
| PRIMARY | Social Responsiveness Scale-2 (SRS-2) Total Score at Week 8 | Week 8 | T-score | LEAST_SQUARES_MEAN | |
| PRIMARY | Social Responsiveness Scale-2 (SRS-2) Total Score at Week 12 | Week 12 | T-score | LEAST_SQUARES_MEAN | |
| PRIMARY | Social Responsiveness Scale-2 (SRS-2) Total Score at Week 16 | Week 16 | T-score | LEAST_SQUARES_MEAN | |
| SECONDARY | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Awareness) | Baseline, Week 4, Week 8, Week 12, Week 16 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Cognition) | Baseline, Week 4, Week 8, Week 12, Week 16 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Communication) | Baseline, Week 4, Week 8, Week 12, Week 16 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Social Motivation) | Baseline, Week 4, Week 8, Week 12, Week 16 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Social Responsiveness Scale-2 (SRS-2) Subscale Score (Restricted Interests/Repetitive Behaviors) | Baseline, Week 4, Week 8, Week 12, Week 16 | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 outcomesResults by group296
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Social Responsiveness Scale-2 (SRS-2) Total Score at Baseline | Sulforaphane | 75.6 | Standard Error 7.4 | T-score | |
| Social Responsiveness Scale-2 (SRS-2) Total Score at Baseline | Placebo | 72.6 | Standard Error 4.6 | T-score | |
| Social Responsiveness Scale-2 (SRS-2) Total Score at Week 4 | Sulforaphane | 74.1 | Standard Error 7.4 | T-score | |
| Social Responsiveness Scale-2 (SRS-2) Total Score at Week 4 | Placebo | 74.1 | Standard Error 4.6 | T-score | |
| Social Responsiveness Scale-2 (SRS-2) Total Score at Week 8 | Sulforaphane | 73.7 | Standard Error 7.4 | T-score | |
| Social Responsiveness Scale-2 (SRS-2) Total Score at Week 8 | Placebo | 74.5 | Standard Error 4.6 | T-score | |
| Social Responsiveness Scale-2 (SRS-2) Total Score at Week 12 | Sulforaphane | 75.3 | Standard Error 7.4 | T-score | |
| Social Responsiveness Scale-2 (SRS-2) Total Score at Week 12 | Placebo | 72.9 | Standard Error 4.6 | T-score | |
| Social Responsiveness Scale-2 (SRS-2) Total Score at Week 16 | Sulforaphane | 75.5 | Standard Error 7.4 | T-score | |
| Social Responsiveness Scale-2 (SRS-2) Total Score at Week 16 | Placebo | 72.7 | Standard Error 4.6 | T-score |
1 to 10 of 296Source ClinicalTrials.gov
See all 296 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sulforaphane | 24 | |
| Overall Study | STARTED | Placebo | 24 | |
| Overall Study | COMPLETED | Sulforaphane | 24 | |
| Overall Study | COMPLETED | Placebo | 24 | |
| Overall Study | NOT COMPLETED | Sulforaphane | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Aggression | Psychiatric disorders | Sulforaphane | 2 | 24 | |
| other | Aggression | Psychiatric disorders | Placebo | 2 | 24 | |
| other | Anxiety | Psychiatric disorders | Sulforaphane | 1 | 24 | |
| other | Anxiety | Psychiatric disorders | Placebo | 0 | 24 | |
| other | Appetite Decrease | Gastrointestinal disorders | Sulforaphane | 0 | 24 | |
| other | Appetite Decrease | Gastrointestinal disorders | Placebo | 1 | 24 | |
| other | Difficulty Falling Asleep | Psychiatric disorders | Sulforaphane | 1 | 24 | |
| other | Difficulty Falling Asleep | Psychiatric disorders | Placebo | 0 | 24 | |
| other | Headache | Nervous system disorders | Sulforaphane | 1 | 24 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 24 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sulforaphane | 0 | 24 |
| Total, all-cause mortality | Placebo | 0 | 24 |
| Total, other adverse events | Sulforaphane | 14 | 24 |
| Total, other adverse events | Placebo | 14 | 24 |
| Total, serious adverse events | Sulforaphane | 0 | 24 |
| Total, serious adverse events | Placebo | 0 | 24 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| KL2TR001109 | North Carolina Translational & Clinical Sciences Institute (NC TraCS) | BUSE, JOHN BERNARD; CAREY, TIMOTHY S | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2013 to 2017 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sulforaphane vs Placebo: deaths from any cause | Trial comparisons |
| Sulforaphane vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02909959
GET https://conductscience.org/api/trials/v1/NCT02909959/registered?page=2