Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Sponsor

Helixmith Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04055090

Collaborator

(none)

101

Enrollment

Locations

5.7

Actual Duration (Months)

4.2

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is explore the overall safety profile and durability of efficacy of 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.

Condition or Disease	Intervention/Treatment	Phase
Painful Diabetic Neuropathy Diabetic Neuropathy, Painful	Genetic: Long-Term Follow-Up of Patients who Received VM202 Drug: Long-Term Follow-Up of Patients who Received Placebo

Detailed Description

In the phase III VMDN-003 study, subjects received 2 treatments of either VM202 or placebo administered as intramuscular (IM) injections into bilateral calves on Days 0 and 14, and Days 90 and 104. Primary efficacy was evaluated 90 days following the first injection. The growth potential for HGF make long-term follow-up important both for safety and efficacy: in order for VM202 to be a candidate for chronic treatment of PDPN, it must be demonstrated not to induce unexpected adverse events with repeated dosing; and the potential for reversal or stabilization of diabetic neuropathy using only one or two treatments of VM202 may make it especially attractive compared to current treatments which must be taken daily for the duration of the disease. A safety extension to the VMDN-003 study is therefore warranted.

Study Design

Study Type:

Observational

Actual Enrollment :

101 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 30, 2019

Actual Primary Completion Date :

Jul 24, 2019

Actual Study Completion Date :

Jul 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Subjects who received VM202	Genetic: Long-Term Follow-Up of Patients who Received VM202 No study drug is administered in this study. Patients who received VM202 in a previous trial will be evaluated in this trial for long-term safety and efficacy.
Subjects who received Placebo	Drug: Long-Term Follow-Up of Patients who Received Placebo No study drug is administered in this study. Patients who received Placebo in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Arm

Intervention/Treatment

Subjects who received VM202

Genetic: Long-Term Follow-Up of Patients who Received VM202

No study drug is administered in this study. Patients who received VM202 in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Subjects who received Placebo

Drug: Long-Term Follow-Up of Patients who Received Placebo

No study drug is administered in this study. Patients who received Placebo in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Outcome Measures

Primary Outcome Measures

the difference in long-term safety [Baseline through Day 365 follow up]
defined as occurrence of adverse events - observed between subjects receiving VM202 versus subjects receiving placebo in the VMDN-003 study

Secondary Outcome Measures

The change in the average 24-hour pain score from baseline to the Day 365 follow-up [baseline to the Day 365 follow-up]
The change in the average 24-hour pain score from baseline to the Day 365 follow-up from the Daily Pain and Sleep Interference Diary
The change in the average 24-hour pain score from Day 270 to the Day 365 follow-up [Day 270 to the Day 365 follow-up]
The change in the average 24-hour pain score from Day 270 to the Day 365 follow-up from the Daily Pain and Sleep Interference Diary;
Patient's Global Impression of Change (PGIC) at the Day 365 follow-up [At the Day 365 follow-up]
The patient's global impression of change

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects randomized and dosed in the VMDN-003 study;
Having received all intramuscular injections of study drug on Days 0, 14, 90, and 104 in the VMDN-003 study;
Currently in follow-up for the VMDN-003 study or having completed Day 270 within the last 90 days prior to signing consent.

Exclusion Criteria:

Current use of an investigational drug or treatment; and
Unable or unwilling to give informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Research Center	Phoenix	Arizona	United States	85023
2	Clinical Trials, Inc.	Little Rock	Arkansas	United States	72205
3	15899 Los Gatos-Almaden Road, Ste 12	Los Gatos	California	United States	95032
4	Northern California Research	Sacramento	California	United States	95821
5	Center for Clinical Research	San Francisco	California	United States	94115
6	Neurological Research Institute	Santa Monica	California	United States	90404
7	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
8	Associated Neurologists of Southern Connecticut, PC	Fairfield	Connecticut	United States	06824
9	Innovative Research of West Florida	Clearwater	Florida	United States	33756
10	University of Florida McKnight Brain Institute	Gainesville	Florida	United States	32611
11	UF Health College of Med	Jacksonville	Florida	United States	32207
12	Compass Research, LLC	Orlando	Florida	United States	32806
13	Clinical Research of West Florida	Tampa	Florida	United States	33603
14	Northwestern University	Chicago	Illinois	United States	56001
15	University of Kansas Medical Center Research Institute	Kansas City	Kansas	United States	66160
16	The Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
17	University of Minnesota	Minneapolis	Minnesota	United States	55455
18	Columbia University Medical Center Department of Neurology	New York	New York	United States	10032
19	Raleigh Neurology Associates, P.A.	Raleigh	North Carolina	United States	27607
20	Martin Foot and Ankle	York	Pennsylvania	United States	17402
21	Nerve and Muscle Center of Texas	Houston	Texas	United States	56001
22	University of Utah -Neurology	Salt Lake City	Utah	United States	84112
23	EVMS (Eastern Virginia Medical School)	Norfolk	Virginia	United States	23510
24	Rainier Clinical Research Center, Inc.	Renton	Washington	United States	98057