MedTrace Logo

Pharmacodynamic EffIcacy and Clinical Benefit of AT 007 in Patients With Sorbitol Dehydrogenase (SORD) Deficiency

NCT05397665 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-09-15

No results posted yet for this study

Summary

This study is designed to assess the efficacy and safety of AT-007 treatment in patients with SORD Deficiency. This randomized, double-blind study will assess the effect of AT-007 compared to Placebo in SORD Deficiency in patients for up to 24 months.

Conditions

  • Hereditary Neuropathy Caused by SORD Deficiency

Interventions

DRUG

AT-007

AT-007, aldose reductase inhibitor

DRUG

Placebo

Liquid oral suspension

Sponsors & Collaborators

  • Applied Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael E Shy, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-10-12
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397665 on ClinicalTrials.gov