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Glutathione Oral Supplementation for Autism Spectrum Disorder

Phase 4
Waitlist Available
Led By Karam Radwan, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be checked at 4 weeks, 8 and 12 weeks (total of 3 measurements)
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing if taking a Glutathione supplement by mouth is safe and practical for children and teenagers with Autism Spectrum Disorder (ASD). The goal is to see if it can help reduce problem behaviors and irritability by increasing Glutathione levels in the blood. Recent evidence shows that children with ASD have significantly lower levels of Glutathione than typically developing children.

Eligible Conditions
  • Autism Spectrum Disorder
  • Autism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this will be checked at 4 weeks, 8 and 12 weeks (total of 3 measurements)
This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be checked at 4 weeks, 8 and 12 weeks (total of 3 measurements) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aberrant Child Checklist, looking at change in the subscale of the ABC
Secondary study objectives
Change in Social responsiveness Scale
Change in Vineland Adaptive Behavior Scales
Other study objectives
Change in Clinical Global Impression Scale
Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD)

Side effects data

From 2012 Phase 3 trial • 195 Patients • NCT02311907
23%
Neutrophil count decreased
13%
Anemia
13%
Peripheral sensory neuropathy
11%
Fatigue
10%
White blood cell decreased
7%
Alopecia
6%
Platelet count decreased
6%
Anorexia
5%
Thromboembolic event
4%
Lymphocyte count decreased
3%
Abdominal pain
3%
Nausea
3%
Death NOS
3%
Dyspnea
3%
Constipation
2%
Vomiting
2%
Pain in extremity
2%
Anaphylaxis
2%
Aspiration
2%
Edema limbs
2%
Lung infection
2%
INR increased
2%
Hyperglycemia
2%
Dyspepsia
2%
Arthralgia
2%
Back pain
1%
Hypertension
1%
Pain
1%
Myalgia
1%
Urticaria
1%
Rectal hemorrhage
1%
Infusion related reaction
1%
Small intestinal obstruction
1%
Respiratory failure
1%
Anorectal infection
1%
Dizziness
1%
Rash maculo-papular
1%
Hypokalemia
1%
Edema trunk
1%
Tooth infection
1%
Dry skin
1%
Hot flashes
1%
Enterocolitis infectious
1%
Colonic obstruction
1%
Pruritus
1%
Wheezing
1%
Bladder infection
1%
Nail infection
1%
Papulopustular rash
1%
Paronychia
1%
Sepsis
1%
Skin infection
1%
Soft tissue infection
1%
Peripheral motor neuropathy
1%
Anxiety
1%
Depression
1%
Cough
1%
Pleural effusion
1%
Hypoxia
1%
Alanine aminotransferase increased
1%
Aspartate aminotransferase increased
1%
Hemoglobin increased
1%
Weight gain
1%
Dehydration
1%
Febrile neutropenia
1%
Leukocytosis
1%
Pericardial effusion
1%
Hearing impaired
1%
Abdominal distension
1%
Gastrointestinal disorders - Other, specify
1%
Hypoalbuminemia
1%
Bone pain
1%
Generalized muscle weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
B (Placebo, Paclitaxel)
A (Glutathione, Carboplatin)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Glutathione Oral SupplementationExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glutathione
2016
Completed Phase 3
~1760

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,048 Previous Clinical Trials
758,548 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
246 Patients Enrolled for Autism Spectrum Disorder
Karam Radwan, MDPrincipal InvestigatorUniversity of Chicago
~1 spots leftby Oct 2025
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