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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Treatments: Suramin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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