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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

Summary

This trial will test if giving oral Glutathione to 24 kids/teens with ASD is safe & effective. Results will help understand its use in treating the disorder.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aberrant Child Checklist, looking at change in the subscale of the ABC
Secondary outcome measures
Change in Social responsiveness Scale
Change in Vineland Adaptive Behavior Scales
Other outcome measures
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%
Anorexia
6%
Platelet count decreased
5%
Thromboembolic event
4%
Lymphocyte count decreased
3%
Constipation
3%
Nausea
3%
Death NOS
3%
Dyspnea
3%
Abdominal pain
2%
Pain in extremity
2%
Edema limbs
2%
Dyspepsia
2%
Vomiting
2%
Lung infection
2%
Hyperglycemia
2%
Aspiration
2%
INR increased
2%
Arthralgia
2%
Back pain
2%
Anaphylaxis
1%
Hot flashes
1%
Hearing impaired
1%
Enterocolitis infectious
1%
Myalgia
1%
Pericardial effusion
1%
Dry skin
1%
Weight gain
1%
Febrile neutropenia
1%
Colonic obstruction
1%
Infusion related reaction
1%
Pain
1%
Nail infection
1%
Paronychia
1%
Hypoalbuminemia
1%
Peripheral motor neuropathy
1%
Anxiety
1%
Hypoxia
1%
Pleural effusion
1%
Hypertension
1%
Gastrointestinal disorders - Other, specify
1%
Small intestinal obstruction
1%
Bone pain
1%
Leukocytosis
1%
Papulopustular rash
1%
Respiratory failure
1%
Urticaria
1%
Generalized muscle weakness
1%
Rash maculo-papular
1%
Tooth infection
1%
Hemoglobin increased
1%
Cough
1%
Abdominal distension
1%
Bladder infection
1%
Sepsis
1%
Aspartate aminotransferase increased
1%
Anorectal infection
1%
Depression
1%
Rectal hemorrhage
1%
Edema trunk
1%
Skin infection
1%
Hypokalemia
1%
Pruritus
1%
Soft tissue infection
1%
Alanine aminotransferase increased
1%
Dehydration
1%
Dizziness
1%
Wheezing
100%
80%
60%
40%
20%
0%
Study treatment Arm
A (Glutathione, Carboplatin)
B (Placebo, Paclitaxel)

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
~1690

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,018 Previous Clinical Trials
734,609 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 Jul 2025