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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be checked at 4 weeks, 8 and 12 weeks (total of 3 measurements)

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

Alopecia

Anorexia

Platelet count decreased

Thromboembolic event

Lymphocyte count decreased

Death NOS

Nausea

Constipation

Dyspnea

Abdominal pain

Edema limbs

Vomiting

Hyperglycemia

Dyspepsia

Pain in extremity

Lung infection

Aspiration

INR increased

Arthralgia

Back pain

Anaphylaxis

Paronychia

Nail infection

Hearing impaired

Infusion related reaction

Myalgia

Colonic obstruction

Small intestinal obstruction

Anxiety

Febrile neutropenia

Bone pain

Pericardial effusion

Dry skin

Hypertension

Hypoxia

Pleural effusion

Weight gain

Peripheral motor neuropathy

Hot flashes

Gastrointestinal disorders - Other, specify

Enterocolitis infectious

Leukocytosis

Pain

Papulopustular rash

Respiratory failure

Hypoalbuminemia

Urticaria

Generalized muscle weakness

Rash maculo-papular

Tooth infection

Hemoglobin increased

Cough

Abdominal distension

Bladder infection

Sepsis

Aspartate aminotransferase increased

Anorectal infection

Depression

Rectal hemorrhage

Edema trunk

Skin infection

Hypokalemia

Pruritus

Soft tissue infection

Alanine aminotransferase increased

Dehydration

Dizziness

Wheezing

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,002 Previous Clinical Trials

817,844 Total Patients Enrolled

5 Trials studying Autism Spectrum Disorder

246 Patients Enrolled for Autism Spectrum Disorder

Karam Radwan, MDPrincipal InvestigatorUniversity of Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project permit adults above the age of 35 to partake?

"For this trial, participants must be between the ages of four and seventeen."

Answered by AI

Is enrollment available for this medical study?

"This clinical trial is designed for patients with autism spectrum disorder, aged 4 through 17. The study will take approximately 24 participants in total."

Answered by AI

Are there vacancies for participation in this clinical trial?

"The information hosted on clinicaltrials.gov suggests that this medical trial has already ceased recruitment and was last edited in July 12th 2023. Even though there is no longer any active enrollment, 303 other studies are currently enrolling participants at this time."

Answered by AI

Has the US Food and Drug Administration granted its approval to Glutathione Oral Supplementation?

"Glutathione Oral Supplementation has achieved a rating of 3 on the safety scale, due to its status as an approved therapy in Phase 4 clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Glutathione in Children With Autism Spectrum Disorder

2019. "A Study of Glutathione in Children With Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05954052.