Phase 2
N=10
University of California, San Diego (UCSD) Suramin Autism Treatment-1 (SAT1) Trial
Autism Spectrum Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02508259 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Autism Diagnostic Observation Schedule, 2nd Edition (ADOS2) — -1.6; -0.4 units on a scale — p=0.0028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Suramin (Drug); Saline (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- Male
- Sponsor
- University of California, San Diego
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Autism Diagnostic Observation Schedule, 2nd Edition (ADOS2) |
-1.6; -0.4 | 0.0028 sig |
| PRIMARY Expressive Language |
-4.2; 2.0 | 0.32 |
| SECONDARY Aberrant Behavior Checklist (ABC) |
-4.0; 1.0 | 0.019 sig |
| SECONDARY Autism Treatment Evaluation Checklist (ATEC) |
-2.0; -0.2 | 0.034 sig |
| SECONDARY The Clinical Global Impression - Improvement Scale (CGI-I) |
-1.8; 0.0 | 0.05 |
| SECONDARY Repetitive Behavior Questionnaire |
-3.2; -0.8 | 0.28 |
Summary
This study is designed to test the safety and efficacy of a single, intravenous dose of suramin in autism spectrum disorders (ASD).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02508259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.