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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to month 24
Awards & highlights

INSPIRE Trial 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.Check my eligibility
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.See study design
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.

INSPIRE Trial Eligibility Criteria

Inclusion Criteria

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

INSPIRE Trial 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

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

INSPIRE 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
829 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

Frequently Asked Questions

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

If an individual is under 50, would they still be able to participate in this research?

"Individuals that fall between 18-55 years old are welcome to enroll in this research."

Answered by AI

Could I take part in this experiment if I meet the qualifications?

"The requirements to participate in this study include being between 18-55 years old and having abetalipoproteinemia. Presently, the researchers are looking for 72 individuals to take part in the trial."

Answered by AI

Are we still recruiting patients for this research project?

"That is correct, the online information shows that this trial is open for recruitment and has been since January 1st, 2022. The study requires 72 patients in total from a single site."

Answered by AI

How many people can join this research project?

"That is correct. The online clinicaltrials.gov database says that the study posted on 1/1/2022 is still actively recruiting participants, with the most recent update being made on 5/26/2022. Only 72 patients are needed for this trial taking place at a single location."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Hassman Research Institute
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Pharmacodynamic EffIcacy and Clinical Benefit of AT 007 in Patients With Sorbitol Dehydrogenase (SORD) Deficiency
2022. "Pharmacodynamic EffIcacy and Clinical Benefit of AT 007 in Patients With Sorbitol Dehydrogenase (SORD) Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05397665.
~4 spots leftby Jul 2024
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