Completed PHASE3 INTERVENTIONAL 2-arm NCT04055090

Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Long-term, Prospective, Non-interventional, Extension of a Phase III, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety & Efficacy of Engensis (VM202) in Subjects With Painful Diabetic Peripheral Neuropathy

Sponsor: Helixmith Co., Ltd.

Conditions Diabetic Neuropathy, Painful Painful Diabetic Neuropathy

Interventions Long-Term Follow-Up of Patients who Received Engensis (VM202) Long-Term Follow-Up of Patients who Received Placebo

Updated 11 times since 2019 Last updated: Sep 23, 2025 Started: Feb 4, 2019 Primary completion: Jul 24, 2019 Completion: Jul 24, 2019

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04055090, this PHASE3 trial focuses on Diabetic Neuropathy, Painful and Painful Diabetic Neuropathy and remains completed. Sponsored by Helixmith Co., Ltd., it has been updated 11 times since 2019, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

11 versions recorded

Nov 2025 — Present [monthly]

Completed PHASE3
Mar 2025 — Nov 2025 [monthly]

Completed PHASE3
Sep 2024 — Mar 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Apr 2023 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 6 earlier versions

Sep 2022 — Apr 2023 [monthly]

Completed PHASE3

Phase: None → PHASE3
Sep 2021 — Sep 2022 [monthly]

Completed

Status: Active Not Recruiting → Completed
Jan 2021 — Sep 2021 [monthly]

Active Not Recruiting
May 2020 — Jan 2021 [monthly]

Active Not Recruiting
Nov 2019 — May 2020 [monthly]

Active Not Recruiting

Status: Recruiting → Active Not Recruiting
Sep 2019 — Nov 2019 [monthly]

Recruiting

First recorded

Feb 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Helixmith Co., Ltd.

Data source: Helixmith Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Boston, United States , Clearwater, United States , Gainesville, United States , Houston, United States , Little Rock, United States , Norfolk, United States , Phoenix, United States , Raleigh, United States , Renton, United States , Sacramento, United States and 4 more locations