Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy

PHASE3CompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

February 4, 2019

Primary Completion Date

July 24, 2019

Study Completion Date

July 24, 2019

Conditions
Painful Diabetic NeuropathyDiabetic Neuropathy, Painful
Interventions
GENETIC

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.

DRUG

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.

Trial Locations (14)

23510

EVMS (Eastern Virginia Medical School), Norfolk

27607

Raleigh Neurology Associates, P.A., Raleigh

32611

University of Florida McKnight Brain Institute, Gainesville

33603

Clinical Research of West Florida, Tampa

33756

Innovative Research of West Florida, Clearwater

72205

Clinical Trials, Inc., Little Rock

77030

Nerve and Muscle Center of Texas, Houston

85023

Arizona Research Center, Phoenix

90404

Neurological Research Institute, Santa Monica

94115

Center for Clinical Research, San Francisco

94598

Diablo Clinical Research, Inc., Walnut Creek

95821

Northern California Research, Sacramento

98057

Rainier Clinical Research Center, Inc., Renton

02115

The Brigham and Women's Hospital, Boston

All Listed Sponsors
lead

Helixmith Co., Ltd.

INDUSTRY

NCT04055090 - Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy | Biotech Hunter | Biotech Hunter