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University of California, San Diego (UCSD) Suramin Treatment Trial for Autism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02508259
First Posted: July 24, 2015
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Robert K. Naviaux, University of California, San Diego
July 22, 2015
July 24, 2015
April 27, 2016
May 2015
March 2016   (Final data collection date for primary outcome measure)
  • Joint social attention [ Time Frame: 2 days to 6 weeks ]
    ADOS (autism diagnostic observation schedule) reciprocal social interaction domain scores
  • Receptive language [ Time Frame: 2 days to 6 weeks ]
    Peabody picture vocabulary test (PPVT)
Same as current
Complete list of historical versions of study NCT02508259 on ClinicalTrials.gov Archive Site
  • Social interaction [ Time Frame: 2 days to 6 weeks ]
    Blinded examiner scoring of video recorded ADOS evaluations using elements of the Communication and Symbolic Behavior Scales (CSBS)
  • Expressive language [ Time Frame: 2 days to 6 weeks ]
    Expressive one word picture vocabulary test (EOWPVT)
  • Cortical connectivity [ Time Frame: 2 days to 6 weeks ]
    EEG power and coherence analysis
  • Autonomic nervous system balance [ Time Frame: 2 days to 6 weeks ]
    EKG analysis of heart rate variability
  • Praxia and Motor coordination [ Time Frame: 2 days to 6 weeks ]
    Fine motor and gross motor digital balance board and dynamic gait analysis
  • Aberrant behaviors [ Time Frame: 2 days to 6 weeks ]
    Aberrant behavior checklist (ABC)
  • Autism core and secondary symptoms [ Time Frame: 2 days to 6 weeks ]
    Autism treatment evaluation checklist (ATEC)
  • The Clinical Global Impression - improvement scale (CGI-I) [ Time Frame: 2 days to 6 weeks ]
    7-point scale reflecting the change in core autism behaviors
  • Global assessment of child developmental behaviors [ Time Frame: 2 days to 6 weeks ]
    Child behavior checklist (CBCL)
  • Repetitive Behaviors [ Time Frame: 2 days to 6 weeks ]
    Repetitive behavior questionnaire (RBQ)
Same as current
Not Provided
Not Provided
 
University of California, San Diego (UCSD) Suramin Treatment Trial for Autism
The UCSD Suramin Autism Treatment Trial
This study is designed to test the safety and efficacy of a single, intravenous dose of suramin in autism spectrum disorders (ASD).
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autism Spectrum Disorders
  • Drug: Suramin
    20 mg/kg IV in 50 ml saline over 30 minutes
    Other Name: Germanin
  • Drug: Saline
    50 ml IV over 30 minutes
    Other Name: Normal saline
  • Active Comparator: Suramin
    20 mg/kg suramin in 50 ml of saline by intravenous infusion over 30 minutes
    Intervention: Drug: Suramin
  • Placebo Comparator: Saline
    50 ml of saline by intravenous infusion over 30 minutes
    Intervention: Drug: Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
April 2016
March 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
4 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02508259
15-0134
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: Safety, metabolomic, and completed outcome data will be made available to qualified institutional groups after peer review and publication.
Robert K. Naviaux, University of California, San Diego
University of California, San Diego
Not Provided
Principal Investigator: Robert K Naviaux, MD, PhD University of California, San Diego
University of California, San Diego
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP