Evaluate the Neurological Effects of EryDex on Subjects With A-T (NEAT)
A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Neurological Effects of EryDex on Subjects With Ataxia Telangiectasia (NEAT)
Sponsor: Biotrial
This observational or N/A phase trial investigates Ataxia Telangiectasia and is currently completed. Biotrial leads this study, which shows 19 recorded versions since 2024 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)The EryDex System (EDS) is a combination product that is used to load dexamethasone sodium phosphate (DSP) into autologous erythrocytes (EryDex) which is infused into the patient.
In the placebo arm, the subjects will receive autologous erythrocytes prepared with the EDS process using a placebo solution.
Upon completion of all screening assessments for eligibility, subjects meeting all selection criteria at baseline will be randomized in a 1:1 fashion to EryDex or placebo. Approximately 86 subjects 6- to 9-years-old, approximately 43 per group, will be randomized. Approximately 20 subjects 10 years of age and above, 10 per treatment group, may also be enrolled.
The EryDex System (EDS) is a combination product that is used to load dexamethasone sodium phosphate (DSP) into autologous erythrocytes (EryDex) which is infused into the patient.
In the placebo arm, the subjects will receive autologous erythrocytes prepared with the EDS process using a placebo solution.
Upon completion of all screening assessments for eligibility, subjects meeting all selection criteria at baseline will be randomized in a 1:1 fashion to EryDex or placebo. Approximately 86 subjects 6- to 9-years-old, approximately 43 per group, will be randomized. Approximately 20 subjects 10 years of age and above, 10 per treatment group, may also be enrolled.
Status Flow
Change History
19 versions recorded-
May 4, 2026 — Present [daily]
Completed
Phase: PHASE3 → None
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Feb 2026 — May 2026 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Nov 2025 — Feb 2026 [monthly]
Active Not Recruiting PHASE3
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Oct 2025 — Nov 2025 [monthly]
Active Not Recruiting PHASE3
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Sep 2025 — Oct 2025 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
▶ Show 14 earlier versions
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Jul 2025 — Sep 2025 [monthly]
Recruiting PHASE3
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Jun 2025 — Jul 2025 [monthly]
Recruiting PHASE3
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE3
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Mar 2025 — May 2025 [monthly]
Recruiting PHASE3
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Feb 2025 — Mar 2025 [monthly]
Recruiting PHASE3
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Jan 2025 — Feb 2025 [monthly]
Recruiting PHASE3
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Dec 2024 — Jan 2025 [monthly]
Recruiting PHASE3
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Oct 2024 — Dec 2024 [monthly]
Recruiting PHASE3
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Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE3
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Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE3
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Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Jun 2024 — Jul 2024 [monthly]
Not Yet Recruiting PHASE3
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May 2024 — Jun 2024 [monthly]
Not Yet Recruiting PHASE3
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Feb 2024 — May 2024 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
This is an international, multi-center, randomized, prospective, double-blind, placebo-controlled, Phase 3 study, designed to assess the effect of EryDex (dexamethasone sodium phosphate \[DSP\] in autologous erythrocytes), administered by intravenous (IV) infusion once every 28 days, on neurological symptoms of patients with Ataxia Telangiectasia (A-T).
Contact Information
- Biotrial
- Quince Therapeutics S.p.A.
For direct contact, visit the study record on ClinicalTrials.gov .