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

Trial Summary

What is the purpose of this trial?

This trial tests several treatments for nerve pain in diabetic patients to identify effective therapies for reducing this type of pain.

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 ISA-Specific Therapy for Diabetic Nerve Pain safe for humans?

Mirogabalin, a treatment similar to ISA-Specific Therapy, has shown good tolerability and safety in clinical trials for diabetic nerve pain, indicating it is generally safe for humans. ^{1 2 3 4 5}

How is ISA-specific therapy different from other treatments for diabetic nerve pain?

ISA-specific therapy for diabetic nerve pain may offer a unique approach by targeting specific mechanisms involved in diabetic neuropathy, such as rapid glycemic control, which can lead to treatment-induced neuropathy. This therapy could potentially address the underlying causes of nerve pain differently than standard treatments, which often focus on symptom management with pain relievers or antidepressants. ^{6 7 8 9 10}

Research Team

Jessica Robinson-Papp, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Japan 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. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Mirogabalin and emerging therapies for diabetic neuropathy. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacological treatment of diabetic neuropathic pain. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Painful Diabetic Peripheral Neuropathy: Practical Guidance and Challenges for Clinical Management. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Enriched enrollment randomized double-blind placebo-controlled cross-over trial with phenytoin cream in painful chronic idiopathic axonal polyneuropathy (EPHENE): a study protocol. [2022]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Insulin neuritis and diabetic cachectic neuropathy: a review. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Diabetic somatic polyneuropathy. Pathogenesis, clinical manifestations and therapeutic concepts]. [2006]

8. England pubmed.ncbi.nlm.nih.gov

'Insulin neuritis' to 'treatment-induced neuropathy of diabetes': new name, same mystery. [2016]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Common and less common peripheral nerve disorders associated with diabetes. [2019]

10. Japan pubmed.ncbi.nlm.nih.gov

Spectrum of diabetic neuropathies. [2023]