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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 0 days

Summary

This trial tests a daily pill called NRD135S.E1 for people with painful nerve damage from diabetes. The study will see if taking this pill for a few months can safely reduce their pain. Researchers aim to understand how well the drug works and if it is safe to use.

Who is the study for?

This trial is for people with Type 2 Diabetes who have been experiencing pain in their legs, feet, toes, or ankles due to diabetic peripheral neuropathy for at least six months. They should score ≥3 on a specific neuropathy screening and report a certain level of pain over the last week.

What is being tested?

The study tests NRD135S.E1 (a new medication) against a placebo to see if it can safely reduce pain from diabetic nerve damage. Participants will take either the medication or placebo once daily for 13 weeks.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with treatments for neuropathic pain may include dizziness, sleepiness, nausea, and headache. The trial aims to assess both safety and efficacy.

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.

Timeline

Screening ~ 1 day1 visit

Treatment ~ 6 months9 visits

Follow Up ~ 0 days0 visits

Screening ~ 1 day

Treatment ~ 6 months

Follow Up ~0 days

This trial's timeline: 1 day for screening, 6 months for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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

Other study objectives

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.

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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