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NCT05397665 · ClinicalTrials.gov registry record · Phase 2
Pharmacodynamic EffIcacy and Clinical Benefit of AT 007 in Patients With Sorbitol Dehydrogenase (SORD) Deficiency
A Phase 2 study of Hereditary Neuropathy Caused by SORD Deficiency, sponsored by Applied Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 10
- Study locations
NCT05397665: Active Phase 2 study of Hereditary Neuropathy Caused by SORD Deficiency, sponsored by Applied Therapeutics.
NCT05397665 is a Phase 2 study of Hereditary Neuropathy Caused by SORD Deficiency that is active but no longer recruiting, run by Applied Therapeutics. The registered enrollment target is 56 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05397665, a Phase 2 study of Hereditary Neuropathy Caused by SORD Deficiency, is active but no longer recruiting, sponsored by Applied Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
The 10MWRT is a timed functional test used to measure walking or running speed over 10 meters by the study population
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AT-007
Study Locations (10)
Colorado
- University of Colorado - Aurora
Florida
- University of Miami - Coral Gables
Iowa
- University of Iowa - Iowa City
Massachusetts
- Massachusetts General Hospital - Boston
New Jersey
- Hassman Research Institute - Berlin
New York
- University of Rochester - Rochester
Pennsylvania
- University of Pennsylvania - Philadelphia
Prague
- Axon Clinical, s.r.o. - Prague
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What the registry record for NCT05397665 still lists
NCT05397665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Hereditary Neuropathy Caused by SORD Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05397665 lists 10 locations in 10 states (Colorado, Florida, Iowa).
Frequently Asked Questions
What is clinical trial NCT05397665 about?
NCT05397665 is a clinical study titled "Pharmacodynamic EffIcacy and Clinical Benefit of AT 007 in Patients With Sorbitol Dehydrogenase (SORD) Deficiency". 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.
What is the current status of trial NCT05397665?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2022-01-01. Estimated completion is 2026-10.
What conditions does trial NCT05397665 study?
This clinical trial studies the following conditions: Hereditary Neuropathy Caused by SORD Deficiency.
What interventions are being tested in trial NCT05397665?
The interventions under investigation include: Placebo (DRUG), AT-007 (DRUG).
Who is sponsoring clinical trial NCT05397665?
This trial is sponsored by Applied Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05397665 being conducted?
This trial has 10 study locations across Colorado, Florida, Iowa, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05397665's enrollment target sits among peer trials
56 1146th of 2000 higher than 848 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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