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Suramin

Phase 2

Autism Spectrum Disorder | Small Molecules | Psychiatry |PaxMedica, Inc.|Trials Updated: Nov 13, 2023

Suramin target and mechanism

Molecular targetFGF1
Target classInhibitor
ModalitySmall Molecules

Also known as Suramin Sodium

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Suramin clinical trials

Suramin · 1 trial · 1 indication

Phase 2 1
NCT06058962Double Blind Trial in Children With Autism Spectrum DisorderAutism Spectrum Disorder
COMPLETED52 Analytics
PHASE2COMPLETED
Double Blind Trial in Children With Autism Spectrum Disorder
Autism Spectrum DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective was to evaluate the safety of 2 dose levels of low-dose suramin against placebo in children with ASD receiving standard treatment.
98 Days

Adverse Events and Laboratory Results

Secondary Endpoints

The primary objective was to evaluate the efficacy of 2 dose levels of low-dose suramin against placebo in children with ASD receiving standard treatment.
98 Days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Suramin 10 mg/kgEXPERIMENTAL50 mg test dose of suramin (upon first administration), then suramin 10 mg/kg (minus 50 mg suramin test dose) in 50 mL of saline administered by IV infusion over 30 minutes was given at Visits 2, 4, and 5.
Suramin 20 mg/kgEXPERIMENTAL50 mg test dose of suramin (upon first administration), then suramin 20 mg/kg (minus 50 mg suramin test dose) in 50 mL of saline administered by IV infusion over 30 minutes was given at Visits 2, 4, and 5.
PlaceboPLACEBO_COMPARATORTest dose of saline placebo, then saline placebo infusion of 50 mL administered over 30 minutes was given at Visits 2, 4, and 5.

Interventions

NameTypeDescription
Suramin SodiumDRUGSuramin sodium is a sodium salt form of suramin, an antitrypanosomal compound.
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Eligibility Criteria

Age Range4 Years to 17 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male children aged 4 - 17 years * Participants with or without treatment interventions for ASD * Participants must have been diagnosed with ASD by Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) * Autism diagnostic observation schedule, version 2 (AD...

Countries:United States
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Competitive Landscape -Autism Spectrum Disorder 21 trials

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