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Corticosteroid

Dexamethasone sodium phosphate for Ataxia Telangiectasia (NEAT Trial)

Phase 3

Waitlist Available

Research Sponsored by Quince Therapeutics S.p.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to visit 9 (approximately 6 months)

Awards & highlights

NEAT Trial Summary

"This trial is being conducted in multiple countries and centers. It is a Phase 3 study that is double-blind and placebo-controlled. The study aims to see how EryDex, which is a

Who is the study for?

This trial is for individuals with a body weight of at least 15 kg who have been clinically diagnosed with Ataxia Telangiectasia (A-T). Participants should be able to walk on their own or occasionally use support and must have genetic confirmation of A-T.Check my eligibility

What is being tested?

The study is testing EryDex, which is dexamethasone sodium phosphate inside red blood cells. It's given through an IV once every month. The goal is to see if it helps with neurological symptoms in A-T patients compared to a placebo.See study design

What are the potential side effects?

Possible side effects from the treatment could include those associated with dexamethasone such as increased appetite, mood changes, trouble sleeping, and higher risk of infections.

NEAT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to visit 9 (approximately 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to visit 9 (approximately 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to visit 9 (approximately 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rescored modified International Cooperative Ataxia Rating Scale (RmICARS)

Secondary outcome measures

Clinical Global Impression of Change (CGI-C)

Clinical Global Impression of Severity (CGI-S)

NEAT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Dexamethasone sodium phosphateExperimental Treatment1 Intervention

IV infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using the EryDex System (EDS)

Group II: PlaceboPlacebo Group1 Intervention

IV infusion of placebo encapsulated in autologous erythrocytes using the EryDex System (EDS)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone sodium phosphate

2010

Completed Phase 2

~100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Quince Therapeutics S.p.A.Lead Sponsor

7 Previous Clinical Trials

389 Total Patients Enrolled

3 Trials studying Ataxia Telangiectasia

288 Patients Enrolled for Ataxia Telangiectasia

BiotrialIndustry Sponsor

10 Previous Clinical Trials

700 Total Patients Enrolled

ErydelLead Sponsor

7 Previous Clinical Trials

389 Total Patients Enrolled

3 Trials studying Ataxia Telangiectasia

288 Patients Enrolled for Ataxia Telangiectasia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different facilities is this research study currently being administered?

"This research project is being conducted at reputable institutions such as The Johns Hopkins Hospital, Division of Pediatric Allergy and Immunology in Baltimore, Maryland; Cincinnati Children's Hospital, Division of Neurology in Cincinnati, Ohio; and UT Health Houston, Department of Pediatrics, Division of Child & Adolescent Neurology in Houston, Texas. Additionally, there are 15 more sites participating across the country."

Answered by AI

Is this clinical trial actively seeking participants at the moment?

"The current data on clinicaltrials.gov indicates that patient recruitment for this study is not ongoing. Initially shared on April 1, 2024, and last revised on April 11, 2024. Despite the lack of availability in this trial, it's worth noting that there are currently 57 other active clinical trials open to enrollment."

Answered by AI

What are the potential risks and safety concerns associated with administering Dexamethasone sodium phosphate to patients?

"Our analysis at Power assigns a safety rating of 3 to Dexamethasone sodium phosphate based on the cumulative evidence from Phase 3 trials, which indicates both efficacy and robust safety profiles."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

To Evaluate the Effects of EryDex in Patients With A-T

2024. "To Evaluate the Effects of EryDex in Patients With A-T". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06193200.

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