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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-04-30

Brief Summary

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

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Detailed Description

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This study is designed to test a new theory of the origin and treatment of ASD. In this theory, ASD is caused by both genes and environment interacting to produce a persistent cell danger response (CDR; Naviaux RK, 2014) that interferes with and alters normal child brain development. Gut microbiome and immune systems are also affected. In this theory, the pathological persistence of the cell danger response is traceable to mitochondria, and maintained by purinergic signaling mediated by the release of extracellular nucleotides like adenosine triphosphate (ATP), adenosine diphosphate (ADP), uridine triphosphate (UTP), and uridine diphosphate (UDP). Suramin inhibits excess purinergic signaling by acting as a competitive inhibitor of nucleotide signaling at both ionotropic purinergic (P2X) receptors, and G-protein coupled, metabotropic purinergic (P2Y) receptors. Suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism (Naviaux JC, et al. 2015; Naviaux JC, et al. 2014; Naviaux RK, et al. 2013). This study will test the safety and efficacy of a single dose of suramin in children with ASD. While it is not anticipated that a single dose will produce benefits for more than a few weeks, if successful, this study may lead to the development of newer and safer drugs for autism treatment.

Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Suramin

20 mg/kg suramin in 50 ml of saline by intravenous infusion over 30 minutes

Group Type ACTIVE_COMPARATOR

Suramin

Intervention Type DRUG

20 mg/kg IV in 50 ml saline over 30 minutes

Saline

50 ml of saline by intravenous infusion over 30 minutes

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

50 ml IV over 30 minutes

Interventions

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Suramin

20 mg/kg IV in 50 ml saline over 30 minutes

Intervention Type DRUG

Saline

50 ml IV over 30 minutes

Intervention Type DRUG

Other Intervention Names

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Germanin Normal saline

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No