CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
EGCG FontUp +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03624556
NCT03624556N/ACompleted
CompareCT.gov

Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS)

Parc de Salut Mar·interventional·Posted Aug 10, 2018·Updated Jun 11, 2021

In Brief

A clinical study evaluating EGCG FontUp and Placebo FontUp for Down Syndrome and Fragile X Syndrome. Completed, enrolled 76 participants across 1 site.

Detailed Summary

To evaluate safety and tolerability of epigallocatechin gallate (EGCG) in children from 6 to 12 years old with Intellectual Developmental Disorders (IDD) (Down syndrome or Fragile X syndrome).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDown Syndrome, Fragile X Syndrome
CountriesSpain
CollaboratorsHospital Infantil Universitario Niño Jesús, Madrid, Spain, Instituto Hispalense de Pediatría, Sevilla, Spain, Hospital Universitario Marqués de Valdecilla, Institut Jerome Lejeune

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 10, 2018
Enrollment StartJan 29, 2018
Primary CompletionMar 29, 2020
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.9 years ago

Interventions

EGCG FontUpdietary

Intake of 10mg/kg/day of EGCG, in the form of a dietary supplement (FontUp), two times a day.

Placebo FontUpother

Intake of placebo, in the form of a dietary supplement (FontUp) (without EGCG), two times a day.