Engensis for Painful Diabetic Peripheral Neuropathy

(REGAiN-1B Trial)

Recruiting at-1 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Helixmith Co., Ltd.

Pivotal Trial (Near Approval)

Prior Safety Data

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.

Research Team

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.

Treatment Details

Interventions

• Engensis (Gene Therapy)
• Placebo (Other)

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+