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Pediatric Exploratory Research Study of EGCG Use and Safety (PERSEUS) | Clinical Trials | Clareo Health

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

NCT03624556•Parc de Salut Mar

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).

Detailed Description

This project first objective is to evaluate the safety and tolerability of the EGCG molecule (extracted form green tea) on children from 6 to 12 years old with Intellectual Development Disorder (Down syndrome and Fragile X syndrome). The secondary objective is to evaluate the benefits of the EGCG on attention, memory, executive functions, language and adaptive behaviour of these children. Dyrk1A and homocysteine in plasma will also be quantified, using them as biomarkers of efficacy.

Eligibility

Age

6 - 12 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males and females aged 6 to 12 years on day 1 of treatment.
•Clinical diagnosis of DS (full trisomy 21 or translocated) confirmed by chromosomal analysis (karyotyping) (Cohort I) or molecular diagnosis for FXS (mutations or premutations on the fragile mental retardation 1 gene-Fmr1 of the X chromosome) (Cohort II). A karyotype will be performed if not available in DS population. FXS molecular diagnosis will be performed if not available in FXS population.
•A body-weight under 50 kg.
•Parent or legal guardian/representative and caregiver willing to give written informed consent.
•Mental age ≥ 3 years (Brunet-Lézine scale C version, picture naming and receptive vocabulary of the WPPSI-IV)
•Study participants must have sufficient vision and hearing to participate in study evaluations. Mild hearing loss will be allowed.
•Availability of parent/caregiver to accompany the subject to clinical visits, provide information about the subject's behavior and symptoms and ensure compliance with the medication schedule.
•Subjects must be able to understand basic instructions. Naming and comprehension tasks of the WPPSI-IV will be used as an evaluation

Exclusion Criteria

•Study participants with a current Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of any primary psychiatric diagnosis (including autism spectrum disorder). For secondary diagnoses, such as attention deficit hyperactivity disorder, depression and conduct disorder, individuals under a fixed regime of medication (a regime that does not change in the 6 weeks prior to enrollment) are allowed as long as they are considered stable and their medication does not interfere with the progression of the study.
•Personal history of infantile spasms, of epilepsy, of severe head trauma or Central Nervous System (CNS) infections (e.g. meningitis), with the exception of a single isolated febrile seizure.
•Subjects with past history of seizures from primary causes (such as West syndrome and Lennox-Gastaut syndrome) or secondary causes.
•Clinical history of moderate or severe Obstructive Sleep Apnea (OSA) as defined by Apnea-Hypopnea Index (AHI) (\>15 events per hour not well controlled by positive airway pressure therapy with stable settings) for at least 3 months prior to screening visit.
•Subjects with thyroid disease that is not controlled (elevated basal Thyroid-stimulating hormone (TSH) \> 10 microU/mL) by thyroid hormone respective therapy.
•Evidence of active, clinically significant, and unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease.
•Cardiovascular, Systolic Blood Pressure (SBP) and/or Diastolic Blood Pressure (DBP) outside the 95th percentile for age; resting heart rate above 100 bpm.
•Cardiovascular, ECG: clinically relevant ECG abnormalities at screening. Auscultation is mandatory part of cardiovascular examination.
•Clinically significant abnormalities in laboratory test results at screening unless acceptable by the investigator.
•Life-threatening illness or major surgery in the 3 months prior to the study.
+5 more criteria

Locations (1)

IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)

Barcelona, Spain

Key Dates

Start Date

January 29, 2018

Primary Completion Date

March 29, 2020

Completion Date

November 30, 2020

Last Updated

June 11, 2021

Enrollment

ACTUAL participants

Conditions

Down SyndromeFragile X Syndrome

Interventions

EGCG FontUp

DIETARY_SUPPLEMENT

Placebo FontUp

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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