Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06058962
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2023-09-18
Brief Title:
Double Blind Trial in Children With Autism Spectrum Disorder
Sponsor:
Paxmedica
Organization:
Paxmedica
Study Overview
Official Title:
A Three-Arm Prospective Randomized Double Blind Placebo-Controlled Trial Evaluating the Efficacy and Safety of 2 Doses of Suramin vs Placebo in Male Children With ASD Receiving Standard Treatment
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study investigated the safe and efficacious use of suramin as a novel treatment for ASD by testing two suramin doses vs placebo
Detailed Description:
PUR-ONQ-ASD-001 was a multicenter 3-arm prospective randomized double blind placebo-controlled multiple dose trial involving 2 dose levels of suramin vs placebo The study randomized 52 male participants who received treatment interventions for ASD each treatment arm was assigned approximately 17 participants The number of participants was increased to 52 participants 48 originally planned due to early withdrawals related to the COVID-19 global pandemic lockdowns and other matters Participants were stratified by age ADOS-2 and Non-verbal Intelligence Quotient NVIQ Participants who met all the inclusion criteria and none of the exclusion criteria were randomized through an electronic system to either arm A 10 mgkg suramin or Arm B 20 mgkg suramin or Arm C Placebo in a targeted 111 ratio as per the randomization schedule and stratified by age ADOS-2 and NVIQ All participants received a 50 mg test dose at their first administration 05 mL of freshly reconstituted 10 solution in 5 mL saline to check for allergic reactions The test dose was given by slow intravenous IV infusion for 30 minutes then flushed with 10 mL saline Vitals were checked for 30 min and if there were no changes or evidence of allergic reaction the rest of the study drug dose was administered 10 mgkg or 20 mgkg minus test dose minus 50 mg in a 50 mL saline up to a maximum of 1 g given over 30 minutes Arm A - 50 mg test dose of suramin upon first administration then suramin 10 mgkg 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 The maximum dose administered was 1 g
Arm B - 50 mg test dose of suramin upon first administration then suramin 20 mgkg 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 The maximum dose administered was 1 g
Arm C - Test dose of saline placebo then saline placebo IV infusion of 50 mL administered over 30 minutes was given at Visits 2 4 and 5
Arm B - 50 mg test dose of suramin upon first administration then suramin 20 mgkg 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 The maximum dose administered was 1 g
Arm C - Test dose of saline placebo then saline placebo IV infusion of 50 mL administered over 30 minutes was given at Visits 2 4 and 5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None