Engensis for Painful Diabetic Peripheral Neuropathy

(REGAiN-1B Trial)

Recruiting at -1 trial locations

Overseen By Louise A. Taber MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Helixmith Co., Ltd.

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying the effects and safety of Engensis, a muscle injection treatment, for patients with Diabetic Peripheral Neuropathy, who suffer from chronic nerve pain due to diabetes. The goal is to see if Engensis can provide lasting pain relief and improve nerve function.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

How is Engensis different from other treatments for painful diabetic peripheral neuropathy?

Engensis is unique because it is a gene therapy, which means it works by delivering specific genes to help repair nerve damage, unlike most other treatments that focus on symptom relief. This approach aims to address the underlying cause of the neuropathy rather than just managing pain. ^{1 2 3 4 5}

Eligibility Criteria

Inclusion Criteria

Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b

Completed study VMDN-003-2 and consent to enroll in study VMDN-003-2b

Exclusion Criteria

There are no specific exclusion criteria for this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants received intramuscular administration of Engensis or Placebo in the double-blind, randomized, placebo-controlled Phase 3 Study VMDN-003-2

6 months

Extension

This 6-month extension study evaluates the durability of efficacy and long-term safety of Engensis or Placebo without administering any treatment

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain scores and adverse events

6 months

Treatment Details

Interventions

• Engensis
• Placebo

Participant Groups

Group I: Engensis Experimental Treatment 1 Intervention

Patients who have received Engensis in protocol VMDN-003-2

Group II: Placebo Placebo Group 1 Intervention

Patients who have received Placebo in protocol VMDN-003-2

Who Is Running the Clinical Trial?

Helixmith Co., Ltd.

Lead Sponsor

Trials

20

Recruited

1,300+

Findings from Research

The meta-analysis of 8 studies involving 656 patients showed that Tongmai Jiangtang capsules (TJC) combined with conventional treatment significantly improved nerve conduction velocities in diabetic peripheral neuropathy (DPN) patients compared to conventional treatment alone.

No adverse drug reactions were reported with the use of TJC, indicating a favorable safety profile, but the authors caution that the results should be interpreted carefully due to significant variability in the data across studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Tongmai Jiangtang capsule combined with conventional therapy in the treatment of diabetic peripheral neuropathy: a systematic review and meta-analysis. Sun, LX., Li, YY., Xie, YM.[2023]

In a systematic review of 21 studies involving 2425 patients with painful diabetic neuropathy, the average placebo response showed a significant reduction in pain intensity, with a moderate effect size of 0.72, indicating that many patients experienced relief even without active treatment.

The study found that over half (53.3%) of patients in the placebo groups reported adverse events, with 5.1% dropping out due to these events, highlighting the importance of understanding both the benefits and potential risks associated with placebo treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in painful diabetic neuropathy: systematic review and meta-analysis. Frisaldi, E., Vollert, J., Al Sultani, H., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Electroacupuncture is not effective in chronic painful neuropathies. [2011]

2. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Buyang Huanwu decoction for diabetic peripheral neuropathy: a systematic review and Metaanalysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effects of treatments for symptoms of painful diabetic neuropathy: systematic review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Tongmai Jiangtang capsule combined with conventional therapy in the treatment of diabetic peripheral neuropathy: a systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in painful diabetic neuropathy: systematic review and meta-analysis. [2023]