Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Down Syndrome (DS)Fragile X Syndrome (FXS)Intellectual Development Disorder (IDD)FontUpEGCGEpigallocatechin gallateDual specificity tyrosine-phosphorylation-regulated kinase 1A (Dyrk1A)HomocysteineDietary supplementGreen teaIMIMPERSEUS

Outcome Measures

Primary Outcomes (8)

Safety Outcome Measure : Adverse Events
Medical evaluations of incidence, nature, severity and causality of Adverse Events and Serious Adverse Events (SAE).
From day -5 to day 252 (through study completion)
Safety Outcome Measure: Number of participants with treatment-related adverse events with supporting evidence with blood analysis: Changes in liver function
The finding of an elevated alanine transaminase (ALT) or aspartate transaminase (AST) (\>3xULN), elevated total bilirubin (\>2xULN)
Days -5, 5, 42, 84, 126, and 168.
Safety Outcome Measure: Number of participants with treatment-related adverse events with supporting evidence with blood analysis: Changes in thyroid function
Elevated TSH (\>10 microU/mL) or any decrease of free T4 below the lower limit of normal values (\<0.8 ng/dL)

Study Arms (2)

Experimental group DS and FXS

EXPERIMENTAL

Cohort 1: a 35 DS children group taking EGCG FontUp. Cohort 2: a 6 FXS children group taking EGCG FontUp. (Experimental open-label)

Dietary Supplement: EGCG FontUp

Control group DS

PLACEBO COMPARATOR

Cohort 1: a 35 DS children group taking placebo FontUp.

Other: Placebo FontUp

Interventions

EGCG FontUpDietary supplement

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

Experimental group DS and FXS

Placebo FontUpOther

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

Control group DS

Eligibility Criteria

Age6 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

Sponsors & Collaborators

Instituto Hispalense de Pediatría, Sevilla, Spain
Type not reportedcollaborator
Institut Jerome Lejeune
Othercollaborator

Study Sites (1)

IMIM (Institut Hospital del Mar d'Investigacions Mèdiques)

Barcelona, 08003, Spain

Related Publications (20)

Nagle DG, Ferreira D, Zhou YD. Epigallocatechin-3-gallate (EGCG): chemical and biomedical perspectives. Phytochemistry. 2006 Sep;67(17):1849-55. doi: 10.1016/j.phytochem.2006.06.020. Epub 2006 Jul 31.
PMID: 16876833BACKGROUND
Megarbane A, Ravel A, Mircher C, Sturtz F, Grattau Y, Rethore MO, Delabar JM, Mobley WC. The 50th anniversary of the discovery of trisomy 21: the past, present, and future of research and treatment of Down syndrome. Genet Med. 2009 Sep;11(9):611-6. doi: 10.1097/GIM.0b013e3181b2e34c.
PMID: 19636252BACKGROUND

MeSH Terms

Conditions

Down SyndromeFragile X SyndromeIntellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornX-Linked Intellectual DisabilitySex Chromosome DisordersGenetic Diseases, X-Linked

Enrollment

76 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: The treatment consists in FontUp (EGCG on a dietary supplement with chocolate like shake flavor) taken dissolved in 100mL of water two times a day (breakfast and afternoon snack). The placebo treatment is the same product but without the EGCG in it, taken with the same posology.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of the Neurosciences Department in Institut Hospital d'Investigacions Mèdiques (IMIM), PharmD, PhD

Study Record Dates

You may not qualify if:

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.
Concomitant disease or condition or any clinically significant finding at screening that could interfere with the conduct of the study, or that would, in the opinion of the investigator, could lead to an unacceptable risk to the subject in this study.
Patients with risk factors of liver dysfunction such as previous history of liver disease, previous clinically significant hepatic abnormalities in laboratory testing, previous allergy or intolerance with liver disorders or any clinically significant abnormalities in hepatic laboratory testing at screening
Participation in other clinical trials in the last 3 months prior to the study.
Concomitant use of unapproved medication.
Current intake of vitamin supplements, catechins or products containing EGCG (i.e. TEAVIGO, Mega Green Tea capsules Life Extension or Font-UP Grand Fontaine Laboratories) for at least 3 months previous to the screening.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Study Arms (2)

Experimental group DS and FXS

Control group DS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (20)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (9)

Other Outcomes (10)

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Study Arms (2)

Experimental group DS and FXS

Control group DS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (20)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (9)

Other Outcomes (10)

You may not qualify if:

Source record

Locations