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lack of funding and difficulty with phlebotomy in children with Autism
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The aim of this study is to investigate if taking a supplement called Glutathione by mouth is safe and practical for children and teenagers with Autism Spectrum Disorder (ASD). The researchers plan to involve 24 individuals with ASD and give them oral Glutathione for 12 weeks.
The goal of the proposed study is to evaluate the safety and feasibility of oral Glutathione in children and adolescents who have Autism Spectrum Disorder. Twenty-four subjects with ASD will receive 12 weeks of oral Glutathione reduced. The hypothesis to be tested is that: Oral Glutathione will be effective in increasing the blood level of Glutathione, which may help to decrease some problem behaviors and irritability in this particular ASD population. The second aim of this study is to evaluate the tolerability of oral Glutathione. The proposed study may provide needed data for future studies aimed at the treatment of aggressive behaviors that can be seen in this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutathione Oral Supplementation | Experimental | Glutathione will be the only study medication dispensed to subjects for this study. Subjects will be told to take the first dose of study medication after breakfast each day and the second dose in the evening after dinner. The proposed dose range for Glutathione in this study will be 1000mg-3000mg/day based on the subject's weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutathione | Drug | Giving supplement orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Child Checklist, Looking at Change in the Subscale of the ABC | The Aberrant Behavior Checklist (ABC) measures psychiatric symptoms and behavioral disturbances in individuals with IDD across five subscales: Irritability (0-45), Social Withdrawal (0-48), Stereotypic Behavior (0-21), Hyperactivity (0-48), and Inappropriate Speech (0-12). Each subscale score is summed to calculate a total score ranging from 0 to 174. Higher scores indicate worse outcomes, with no specific cutoff values, as the measure is used alongside diagnostic tools like the Autism Diagnostic Observation Schedule (ADOS). The ABC is designed to establish baseline symptoms and monitor changes over time, where a decrease in scores reflects improvement, and an increase indicates worsening symptoms.The Aberrant Behavior Checklist (ABC) consists of five subscales: Irritability (0-45), Lethargy (0-48), Stereotypic Behavior (0-21), Hyperactivity (0-48), and Inappropriate Speech (0-12). Higher scores represent more severe symptoms. The total ABC score ranges from 0 to 174 | baseline and 12 weeks. To clarify, all pre-specified Primary and Secondary Outcome Measures were collected at baseline and the 12-week endpoint only. No intermediate assessments were conducted. |
| Measure | Description | Time Frame |
|---|---|---|
| Social Responsiveness Scale | The Social Responsiveness Scale, Second Edition (SRS-2) is a 65-item caregiver-rated questionnaire that measures the severity of social impairments associated with autism spectrum disorder (ASD) in children and adolescents (ages 2 years 6 months to 18 years). It assesses five domains: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior, as well as a Total Score. T-scores typically range from approximately 30 to 90+, with scores capped at 90 in cases of severe impairment. Higher T-scores indicate greater severity of social impairment (worse outcome), while lower T-scores indicate fewer social difficulties (better outcome). Clinically Relevant Thresholds T-score ≤ 59: Within normal limits T-score 60-65: Mild range (borderline, subclinical difficulties) T-score 66-75: Moderate range (clinically significant impairment) T-score ≥ 76: Severe range (marked impairment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Global Impression Scale | The Clinical Global Impression (CGI) is a clinician-rated instrument developed for use in NIMH-sponsored clinical trials to provide a brief global assessment of illness severity, improvement, and therapeutic efficacy. The three commonly reported CGI scales are: CGI-Severity (CGI-S): Rates current illness severity from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). CGI-Improvement (CGI-I): Rates change in clinical status from baseline on a 7-point scale, ranging from 1 (Very much improved) to 7 (Very much worse). CGI-Efficacy Index (CGI-E): Balances therapeutic efficacy with adverse effects, rated on a 4 × 4 grid, where higher scores reflect minimal efficacy and/or significant side effects. Lower CGI-S and CGI-I scores indicate better outcomes (less illness severity and/or greater improvement). Higher CGI-E scores reflect worse outcomes (limited efficacy and/or significant side effects). Higher CGI-E scores reflect worse outcomes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karam Radwan, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
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Following the completion of the trial and until 2 years from the publication of the trial outcome data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glutathione Oral Supplementation | Glutathione will be the only study medication dispensed to subjects for this study. Subjects will be told to take the first dose of study medication after breakfast each day and the second dose in the evening after dinner. The proposed dose range for Glutathione in this study will be 1000mg-3000mg/day based on the subject's weight. Glutathione: Giving supplement orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glutathione Oral Supplementation | Glutathione will be the only study medication dispensed to subjects for this study. Subjects will be told to take the first dose of study medication after breakfast each day and the second dose in the evening after dinner. The proposed dose range for Glutathione in this study will be 1000mg-3000mg/day based on the subject's weight. Glutathione: Giving supplement orally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aberrant Child Checklist, Looking at Change in the Subscale of the ABC | The Aberrant Behavior Checklist (ABC) measures psychiatric symptoms and behavioral disturbances in individuals with IDD across five subscales: Irritability (0-45), Social Withdrawal (0-48), Stereotypic Behavior (0-21), Hyperactivity (0-48), and Inappropriate Speech (0-12). Each subscale score is summed to calculate a total score ranging from 0 to 174. Higher scores indicate worse outcomes, with no specific cutoff values, as the measure is used alongside diagnostic tools like the Autism Diagnostic Observation Schedule (ADOS). The ABC is designed to establish baseline symptoms and monitor changes over time, where a decrease in scores reflects improvement, and an increase indicates worsening symptoms.The Aberrant Behavior Checklist (ABC) consists of five subscales: Irritability (0-45), Lethargy (0-48), Stereotypic Behavior (0-21), Hyperactivity (0-48), and Inappropriate Speech (0-12). Higher scores represent more severe symptoms. The total ABC score ranges from 0 to 174 | All participants who received at least one dose of oral glutathione and had both baseline and Week 12 (or endpoint) Aberrant Behavior Checklist (ABC) assessments available (n=5). One participant discontinued after 2 weeks due to increased irritability and was excluded from the change analysis | Posted | Mean | 62% Confidence Interval | units on a scale | baseline and 12 weeks. To clarify, all pre-specified Primary and Secondary Outcome Measures were collected at baseline and the 12-week endpoint only. No intermediate assessments were conducted. |
12 weeks
collected using interview with the family and patient
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glutathione | We have one arm who took supplement | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 1 | Nervous system disorders | Other | Non-systematic Assessment | one subject had increased irritability and agitation which was resolved after D/C the supplement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 1 | Nervous system disorders | Other | Systematic Assessment | increase irratbility |
Early termination due to lack of funding and difficulty with phlebotomy in children with Autism
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karam Radwan, MD | University of Chicago | 7738346686 | radwan@uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2019 | Aug 7, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 14, 2022 | Aug 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005978 | Glutathione |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| We only have the Social Responsiveness Scale measurement at baseline. |
| At baseline and the end of the trial (12 weeks) |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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| Secondary | Social Responsiveness Scale | The Social Responsiveness Scale, Second Edition (SRS-2) is a 65-item caregiver-rated questionnaire that measures the severity of social impairments associated with autism spectrum disorder (ASD) in children and adolescents (ages 2 years 6 months to 18 years). It assesses five domains: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior, as well as a Total Score. T-scores typically range from approximately 30 to 90+, with scores capped at 90 in cases of severe impairment. Higher T-scores indicate greater severity of social impairment (worse outcome), while lower T-scores indicate fewer social difficulties (better outcome). Clinically Relevant Thresholds T-score ≤ 59: Within normal limits T-score 60-65: Mild range (borderline, subclinical difficulties) T-score 66-75: Moderate range (clinically significant impairment) T-score ≥ 76: Severe range (marked impairment) | All participants who were enrolled and completed the baseline Social Responsiveness Scale (SRS) assessment (n=6) | Posted | Median | Inter-Quartile Range | T-score for this instrument. | We only have the Social Responsiveness Scale measurement at baseline. |
|
|
|
| Other Pre-specified | Change in Clinical Global Impression Scale | The Clinical Global Impression (CGI) is a clinician-rated instrument developed for use in NIMH-sponsored clinical trials to provide a brief global assessment of illness severity, improvement, and therapeutic efficacy. The three commonly reported CGI scales are: CGI-Severity (CGI-S): Rates current illness severity from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). CGI-Improvement (CGI-I): Rates change in clinical status from baseline on a 7-point scale, ranging from 1 (Very much improved) to 7 (Very much worse). CGI-Efficacy Index (CGI-E): Balances therapeutic efficacy with adverse effects, rated on a 4 × 4 grid, where higher scores reflect minimal efficacy and/or significant side effects. Lower CGI-S and CGI-I scores indicate better outcomes (less illness severity and/or greater improvement). Higher CGI-E scores reflect worse outcomes (limited efficacy and/or significant side effects). Higher CGI-E scores reflect worse outcomes | Posted | Median | Inter-Quartile Range | score on a scale | At baseline and the end of the trial (12 weeks) |
|
|
|
| Post-Hoc | Clinical Global Impression - Severity Scale (CGI-S) Range for Participants | Pre-treatment CGI-S ratings ranged from 2 (borderline ill) to 5 (markedly ill). One subject's CGI-S changed from 4 (moderately ill) to 5 (markedly ill); others had no change. | Not Posted | 12 weeks | Participants |
| Post-Hoc | Clinical Global Impression - Improvement Scale: Rates Change in Clinical Status From Baseline on a 7-point Scale, Ranging From 1 (Very Much Improved) to 7 (Very Much Worse). | 1 subject scored 4 (no change), four scored 3 (minimally improved), and one scored 6 (much worse). | Not Posted | 12 weeks | Participants |
| Post-Hoc | CGI-Efficacy Index (CGI-E): Balances Therapeutic Efficacy With Adverse Effects, Rated on a 4 × 4 Grid, Where Higher Scores Reflect Minimal Efficacy and/or Significant Side Effects. | two patients had no therapeutic changes, four had minimal efficacy, five had no side effects, and one dropped out due to significant side effects | Not Posted | 12 weeks | Participants |
| 6 |
| 1 |
| 6 |
| 1 |
| 6 |
|
| irritability | Nervous system disorders | Other | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Social Motivation |
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| Autism Mannerisms |
|
| Total Severity |
|
| Title | Measurements |
|---|---|
|
| Efficacy Index |
|