NEW Diabetes and Pain Medication Study

Recruiting at 20 trial locations

Overseen By Ajay Wasan, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: James P. Rathmell, MD

Must not be taking: Opioids, Marijuana, others

Disqualifiers: Non-diabetic neuropathy, Foot ulcer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, ISA-specific therapy, can alleviate pain from diabetic nerve damage, known as Painful Diabetic Peripheral Neuropathy (PDPN). Participants will receive either the experimental treatment or a placebo (a substance with no active drug) for comparison. The trial seeks individuals who have experienced diabetes and nerve pain symptoms in their lower legs for at least six months. This trial is part of a larger initiative to end long-term addiction by discovering better pain treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires participants to stop using opioids or marijuana and any investigational drugs before and during the study. Additionally, you must discontinue episodic or periodic treatments for pain in the legs and feet, and you cannot start new non-drug pain treatments for diabetic nerve pain close to or during the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that a treatment similar to ISA-Specific Therapy, called Mirogabalin, was safe and well-tolerated in trials for diabetic nerve pain. This suggests that ISA-Specific Therapy might also be safe for people. Another study found that high-frequency spinal cord stimulation, a different treatment for diabetic nerve pain, was effective and safe. Although these studies don't directly involve ISA-Specific Therapy, they help reassure about the safety of treatments for this condition. Please note that this trial is in Phase 2, indicating early promising results, but more research is needed to confirm safety in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ISA-specific therapy for diabetic nerve pain because it offers a novel approach compared to current treatments like gabapentin, pregabalin, or duloxetine. While these standard options primarily aim to manage symptoms by altering neurotransmitter levels, the ISA-specific method might target the underlying pathways of nerve pain more directly. This approach could potentially offer more effective pain relief with fewer side effects, making it a promising alternative for those who struggle with current medications.

What evidence suggests that this treatment might be an effective treatment for diabetic nerve pain?

Research has shown that ISA-specific therapy, which participants in this trial may receive, might help with diabetic nerve pain. In a study involving many patients with this type of pain, mirogabalin provided significant relief. Early studies also suggest that ISA-specific therapy can increase the number of nerve fibers in the skin, potentially aiding nerve regrowth and reducing pain. These findings offer hope that ISA-specific therapy could effectively manage diabetic nerve pain. ^{1 2 3 5 6}

Who Is on the Research Team?

Jessica Robinson-Papp, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for people with Type 2 Diabetes who suffer from painful diabetic neuropathy, specifically pain in the lower extremities. Participants should have stable diabetes treatment for at least three months without expected changes in their medication regimen. Those who've had a recent heart attack or stroke cannot join.

Inclusion Criteria

I have Type 2 Diabetes.

I have diabetic neuropathy.

I experience pain in my legs, feet, toes, or ankles.

Exclusion Criteria

I have had a heart attack or stroke.

My diabetes treatment has been stable for at least 3 months with no expected changes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment for Painful Diabetic Peripheral Neuropathy under a platform protocol to test multiple assets against a placebo

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ISA specific

Trial Overview The study is part of EPPIC-Net and aims to test various treatments for Painful Diabetic Peripheral Neuropathy (PDPN) using a platform protocol that allows multiple drugs to be tested under one overarching study design.

How Is the Trial Designed?

Group I: EN21-01 ISA Experimental Treatment 1 Intervention

The EN21-01 Intervention Specific Analysis is detailed in the protocol (NCT#)

Group II: Placebo Comparator Placebo Group 1 Intervention

Each ISA will detail the use of the Placebo Comparator.

Who Is Running the Clinical Trial?

James P. Rathmell, MD

Lead Sponsor

Trials

2

Recruited

240+

New York University

Collaborator

Trials

249

Recruited

229,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a phase III study involving 834 Asian patients with diabetic peripheral neuropathic pain, mirogabalin demonstrated significant pain relief, particularly at the 30 mg/day dose, compared to placebo, with a notable change in average daily pain score of -1.81 (P = 0.0027).

Mirogabalin was well tolerated across all doses, with most side effects being mild to moderate, including nasopharyngitis, somnolence, and dizziness, indicating a favorable safety profile for this new treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double-blind, placebo-controlled phase III study in Asian patients. Baba, M., Matsui, N., Kuroha, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05480228

NCT05480228 | EPPIC-Net: Novaremed Painful Diabetic ... This ISA describes a double-blind Phase II study of the PK/PD, safety, tolerability, and effect of 13 weeks of NRD135S.E1 (80mg/day) as an ISA within the ...

2. withpower.com withpower.com/trial/phase-2-pain-7-2022-e79ae

ISA-Specific Therapy for Diabetic Nerve Pain In a phase III study involving 834 Asian patients with diabetic peripheral neuropathic pain, mirogabalin demonstrated significant pain relief, particularly at ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9205568/

Diabetes: how to manage diabetic peripheral neuropathy - PMC There is some evidence suggesting that high-frequency spinal cord stimulation (SCS) may be an effective and safe treatment for painful DPN. SCS is conducted via ...

4. reporter.nih.gov reporter.nih.gov/project-details/10267804

EPPIC-Net Pain Research - Application for Clinical Trial ... Preliminary studies showed an increase in nerve fiber density in the skin, suggesting it can enhance nerve regrowth and may help alleviate pain in painful ...

5. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1265372/full

Diabetic peripheral neuropathy: pathogenetic mechanisms ... A six-week treatment regimen of honey plus insulin improved sensory nerve conduction velocity in WBN/Kob rats (100). Insulin administration improves peripheral ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05480228?keyword=%22Painful%22

Novaremed Painful Diabetic Peripheral Neuropathy ISA This ISA describes a double-blind Phase II study of the PK/PD, safety, tolerability, and effect of 13 weeks of NRD135S.E1 (80mg/day) as an ISA within the ...