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Study to Assess Safety and Efficacy of Engensis in Painful Diabetic Peripheral Neuropathy

NCT04469270 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-10-09

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of intramuscular administration of Engensis on pain in participants with painful diabetic peripheral neuropathy in the feet and lower legs, as compared to Placebo, as a second Phase 3, well controlled study, sufficient in supporting the efficacy and safety of Engensis.

Conditions

  • Diabetic Neuropathy, Painful

Interventions

BIOLOGICAL

Engensis

Intramuscular injections

OTHER

Placebo

Intramuscular injections

Sponsors & Collaborators

  • Helixmith Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2023-03-24
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04469270 on ClinicalTrials.gov