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NEW Diabetes and Pain Medication Study (EN21-01 Trial)

Verified Trial

Phase 2

Recruiting

Led By Jessica Robinson-Papp, MD

Research Sponsored by James P. Rathmell, MD

Eligibility Criteria Checklist

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

Must have

Do you have pain in your lower extremities (legs, feet, ankles, toes, etc.)?

Neuropathic symptoms in a distal distribution (e.g., numbness, paresthesia or tingling, sensory distortions or misinterpretations, etc.)

Timeline

Screening 1 day

Treatment 6 months

Follow Up 13 weeks

Awards & highlights

EN21-01 Trial Summary

This trial will investigate whether a current hard gelatin capsule formulation of NRD135S.E1 is safe and effective in treating PDPN when taken once daily for 13 weeks.

Eligible Conditions

Diabetic Neuropathy
Chronic Pain
Peripheral Neuropathy
Diabetes
Neuropathic Pain
Type 2 Diabetes

EN21-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have numbness, tingling, or other unusual sensations in your hands or feet.

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This criteria will be used along with the Platform Protocol criteria.

EN21-01 Trial Timeline

Screening ~ 1 day1 visit

Treatment ~ 6 months9 visits

Follow Up ~ 13 weeks

Screening ~ 1 day

Treatment ~ 6 months

Follow Up ~13 weeks

This trial's timeline: 1 day for screening, 6 months for treatment, and 13 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The frequency (i.e. number of participants) with treatment emergent adverse events (TEAEs) reported in the time period defined by first administration of IP until 7 days after the last dose of IP.

To demonstrate that NRD135S.E1 80 mg daily is superior to placebo in relieving neuropathic pain associated with PDPN, after 13 weeks' treatment.

Secondary outcome measures

Occurrence of 30% reduction of WAP from Baseline to Week 13.

Occurrence of 50% reduction of WAP from Baseline to Week 13.

Other outcome measures

To assess the effect of NRD135S.E1 in comparison to placebo with respect to Pain Catastrophizing Scale - Short Form 6 (PCS-SF6)

To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Generalized Anxiety Disorder - 2 item scale (GAD-2).

To assess the effect of NRD135S.E1 in comparison to placebo with respect to the Neuropathy examination.

+10 more

EN21-01 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NRD135S.E1 80mg/dayExperimental Treatment1 Intervention

NRD135S.E1 as a potential treatment for moderate to severe painful diabetic peripheral neuropathy (PDPN). While the activity of NRD135S.E1 has been extensively studied, its molecular target is not known, though it does not appear to work through any of the opioid receptors or molecular pathways currently targeted by available analgesics. The best evidence suggests it may act, at least in part, through modulating the Lyn kinase signaling pathway In clinical studies, NRD135S.E1 has been well tolerated at all dose levels tested in single-dose (up to 1,200 mg) and repeat-dose regimens (up to 300 mg/day over 5 days or 150 mg over 3 weeks), and it has been shown to have predictable pharmacokinetics with dose-dependent increases in exposure.

Group II: Matching placeboPlacebo Group1 Intervention

A matching placebo comparator will be used.

0 / 5Eligibility criteria met

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

James P. Rathmell, MDLead Sponsor

1 Previous Clinical Trials

122 Total Patients Enrolled

Icahn School of Medicine at Mount SinaiOTHER

858 Previous Clinical Trials

524,164 Total Patients Enrolled

New York UniversityOTHER

226 Previous Clinical Trials

314,133 Total Patients Enrolled

Media Library

NRD135SE.1 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05480228 — Phase 2

Diabetic Neuropathy Research Study Groups: NRD135S.E1 80mg/day, Matching placebo

Diabetic Neuropathy Clinical Trial 2023: NRD135SE.1 Highlights & Side Effects. Trial Name: NCT05480228 — Phase 2

NRD135SE.1 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05480228 — Phase 2

Diabetic Neuropathy Patient Testimony for trial: Trial Name: NCT05480228 — Phase 2

Frequently Asked Questions

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

What are the fundamental goals of this research effort?

"The 13 week trial aims to prove the efficacy of NRD135S.E1 80 mg daily in alleviating neuropathic pain associated with PDPN. Secondary objectives include demonstrating a 30% and 50% reduction in Weekly Average Pain (WAP) from baseline to weeks 12 and 13, respectively."

Answered by AI

What is the enrollment size for this clinical research?

"Yes, the details accessible on clinicaltrials.gov reveal that recruitment for this trial is underway. Initiated on September 21st 2022 and last updated in mid-September, 122 participants are sought from 1 medical centre."

Answered by AI

To what extent can NRD135SE.1 be hazardous for individuals?

"From our team's analysis, NRD135SE.1 falls on a scale of 1 to 3 with 2 indicating that there is some clinical data demonstrating the safety profile but efficacy has yet to be conclusively proven."

Answered by AI

Is recruitment currently open for this trial?

"This research is still searching for suitable participants, with the original listing posted to clinicaltrials.gov on September 21st and last amended on September 14th."

Answered by AI