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Clinical trial

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

ID
Name
VMDN-003b
Description
The purpose of this study is to explore the overall safety profile and durability of efficacy of Engensis (VM202) in painful diabetic peripheral neuropathy. All subjects still in follow-up for the VMDN-003 study or who have completed the Day 270 visit within the prior 90 days will be approached to enroll in the long-term safety extension study.
Trial arms
Trial start
2019-02-04
Estimated PCD
2019-07-24
Trial end
2019-07-24
Status
Completed
Phase
Early phase I
Treatment
Long-Term Follow-Up of Patients who Received Engensis (VM202)
No study drug is administered in this study. Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
Arms:
Subjects who received Engensis (VM202)
Long-Term Follow-Up of Patients who Received Placebo
No study drug is administered in this study. Patients who received Placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this trial for long-term safety and efficacy.
Arms:
Subjects who received Placebo
Size
101
Primary endpoint
Long-term Safety for Engensis Versus Placebo
Baseline through Day 365
Eligibility criteria
Inclusion Criteria: 1. Were randomized and dosed in the VMDN-003 study 2. Received all IM injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study 3. Were in follow-up for the VMDN-003 study or had completed Day 270 within the last 90 days prior to signing consent Exclusion Criteria: 1. Were using an investigational drug or treatment 2. Were unable or unwilling to give informed consent
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Long term, prospective, non-interventional, safety extension study of phase 3 trial. Double blind, randomized, placebo-controlled, multicenter study/', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Double-blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 101, 'type': 'ACTUAL'}}
Updated at
2023-03-08

1 organization

2 products

3 indications

Organization
Helixmith
Product
Engensis
Indication
Painful Diabetic Neuropathy
Indication
Diabetic Neuropathy
Indication
Pain
Product
Long-Term Follow-Up of Patients