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AT-007 for Sensory and Autonomic Neuropathy (INSPIRE Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Applied Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and non-pregnant, non-lactating female patients between the ages of 18 and 55 years, inclusive
Clinical diagnosis of CMT2 or dHMN due to SORD Deficiency confirmed by medical record or written communication by health care professional, elevated sorbitol level (>10,000 ng/mL), and gene analysis report indicating a biallelic mutation in SORD
Must not have
Non-ambulatory disability
10MWRT classified as very severe disease (e.g. 10MWRT >10 seconds to complete)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to month 24

Summary

This trial will study AT-007, a potential treatment for SORD Deficiency, to see if it is effective and safe. Patients will be monitored for 24 months.

Who is the study for?
This trial is for adults aged 18-55 with SORD Deficiency, confirmed by medical records and gene analysis. Participants must have elevated sorbitol levels and agree to use birth control if they can bear children. Excluded are those with very severe disease, significant other health issues, high or low BMI outside set limits, substance abuse history, recent blood donations or participation in another drug study.
What is being tested?
The trial tests the efficacy and safety of AT-007 against a placebo over 24 months in patients with SORD Deficiency. It's randomized and double-blind, meaning neither the researchers nor participants know who receives the actual drug versus the placebo.
What are the potential side effects?
While specific side effects of AT-007 aren't listed here, common ones may include allergic reactions to ingredients, potential gastrointestinal disturbances due to medication intake or possible headaches as often seen with new medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man or a woman not pregnant or breastfeeding, aged 18 to 55.
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I have CMT2 or dHMN with a confirmed SORD mutation and high sorbitol levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot walk on my own.
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It takes me more than 10 seconds to walk 10 meters due to my condition.
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I am not on medication that could affect the study drug.
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I have tested positive for hepatitis B, C, or HIV.
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I haven't donated blood or had significant blood loss in the last 3 months.
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I have had surgery to stabilize both of my ankles.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
10-meter walk-run test (10MWRT).
CMT-Fom (Charcot Marie Tooth Functional Outcome Measure)
Muscle MRI (Magnetic Resonance Imaging)
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: AT-007Active Control1 Intervention
AT-007 is an Aldose reductase inhibitor
Group II: PlaceboPlacebo Group1 Intervention
Is an non-active control

Find a Location

Who is running the clinical trial?

Applied Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
843 Total Patients Enrolled
Michael E Shy, MDStudy ChairUniversity of Iowa
4 Previous Clinical Trials
7,113 Total Patients Enrolled

Media Library

AT-007 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05397665 — Phase 2 & 3
Sensory and Autonomic Neuropathy Research Study Groups: AT-007, Placebo
Sensory and Autonomic Neuropathy Clinical Trial 2023: AT-007 Highlights & Side Effects. Trial Name: NCT05397665 — Phase 2 & 3
AT-007 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397665 — Phase 2 & 3
~14 spots leftby Dec 2025
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