University of California, San Diego (UCSD) Suramin Autism Treatment-1 (SAT1) Trial

Completed · Phase 1/Phase 2

Conditions studied: Autism Spectrum Disorders

In brief

This study is designed to test the safety and efficacy of a single, intravenous dose of suramin in autism spectrum disorders (ASD).

Key facts

Study ID

NCT02508259

Run by

University of California, San Diego

People needed

10

Starts

2015-05-01

Expected to finish

2016-04-01

Last updated by the study team

2019-07-16

Who can join

Age: 4 and older, up to 17. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Autism diagnostic observation schedule (ADOS) score of ≥ 7
• Diagnosis of autism spectrum disorder by Diagnostic and Statistical Manual, 5th edition (DSM-V)
• Stable treatment and diet regimen for ≥ 2 months
• Resident of San Diego region

You may not qualify if…

• Any prescription medications
• Hospitalization within the previous 2 months
• Active medical problem such as seizures, heart, liver, kidney, or adrenal disease
• Planning to start a new drug, diet, or behavioral intervention during the study
• Weight under the 5th percentile for age
• Unable to tolerate venipuncture, urine collection, or an indwelling intravenous catheter for 3-4 hours
• Plasma creatinine ≥ 1.4 mg/dl
• Liver function alanine amino transferase (ALT) or aspartate amino transferase (AST) ≥ 1.5-fold above the upper limit of normal
• Known intolerance to suramin or other antipurinergic drugs
• Unable to perform or cooperate with study requirements

Where it is running

• University of California, San Diego School of Medicine — La Jolla, California, United States

Full record on ClinicalTrials.gov

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