Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

March 2, 2017

Primary Completion Date

May 13, 2021

Study Completion Date

May 13, 2021

Conditions
Nervous System DiseaseGenetic Syndrome
Interventions
DRUG

EryDex Low dose DSP

EDS-EP dose range of \~5-10 mg DSP/infusion

DRUG

EryDex High dose DSP

EDS-EP dose range of \~14-22 mg DSP/infusion

DRUG

Pooled Placebo

EDS processed autologous erythrocytes using a sodium chloride \[NaCl\] solution.

Trial Locations (22)

2010

El Razi Hospital, Manouba

3000

Laboratoriumgeneeskunde, Leuven

3052

Royal Children's Hospital, Melbourne

25123

U.O. Neurologia e Psichiatria dell'Infanzia e dell' Adolescenza. ASST Spedali Civili, Piazzale Spedali Civili, 1, Brescia

52621

Sheba Medical Center, Tel Litwinsky

60590

Klinik für Kinder- und Jugendmedizin Pädiatrische Allergologie, Pneumologie und Mukoviszidose, Universitätsklinikum Frankfurt, Frankfurt am Main

77030

UT Health, Houston

110029

All India Institute of Medical Sciences, New Delhi

400016

PD Hinduja National Hospital and Medical Research, Mahīm

400026

Jaslok Hospital and Research Centre, Mumbai

500082

Nizam's Institute of Medical Sciences, Hyderabad

600026

Vijaya Health Centre, Department of Neurology, Chennai

682041

Amrita Institute of Medical Sciences and Research Centre, Kochi

900951694

UCLA-Ataxia Center and HD Center of Exellence, Los Angeles

21287-3923

The Ataxia-Telangiectasia Clinical Center, The Johns Hopkins Hospital, Baltimore

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

560 029

National Institute of Mental Health and Neurosciences, Bangalore

00185

Dipartimento di Pediatria e Neuropsichiatria Infantile, Università Sapienza di Roma, Azienda Policlinico Universitario Umberto I, Rome

Unknown

Norwegian National Unit for Newborn Screening, Division of Pediatric and Adolescent Medicine, Oslo University Hospital, Oslo

Hospital Universitario La Paz., Madrid

Nottingham University Hospitals NHS Trust - Queen's Medical Centre, Nottingham

04-730

Department of Clinical Immunology The Children's Memorial Health Institute, Warsaw

All Listed Sponsors
lead

Quince Therapeutics S.p.A.

INDUSTRY

NCT02770807 - Intra-Erythrocyte Dexamethasone Sodium Phosphate in Ataxia Telangiectasia Patients | Biotech Hunter | Biotech Hunter