Phase 3 Gene Therapy for Painful Diabetic Neuropathy

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of bilateral intramuscular injections of VM202 versus placebo in the treatment of painful diabetic peripheral neuropathy. A total of 507 of 477 planned participants were randomized in a 2:1 ratio to one of two treatment groups. Note that 500 participants received IP treatment, whereas 7 participants did not receive IP treatment. Treatments - Engensis (VM202) - 336 Engensis of 318 planned participants Control - Placebo (VM202 vehicle) - 164 Placebo of 159 planned participants Randomization were stratified by current use of gabapentin and/or pregabalin.

Clinical Trial Description

Peripheral neuropathy is a serious complication of diabetes. This form of neuropathy carries a high risk of pain, trophic changes, and autonomic dysfunction. Current treatments of diabetic peripheral neuropathy (DPN) are based on either pathogenetic mechanisms or symptomatic relief. A number of clinical trials have established symptomatic treatment but for pathogenetic mechanisms, the only proven treatment strategy is strict glycemic control. Clearly, it would be desirable to prevent, impede, or reverse the disrupting and often life-threatening manifestations of peripheral neuropathy by stimulating growth or regeneration of peripheral nerve axons. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02427464
Study type	Interventional
Source	Helixmith Co., Ltd.
Contact
Status	Completed
Phase	Phase 3
Start date	April 2016
Completion date	April 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04699734` - Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy	N/A
Recruiting	`NCT05476276` - EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy	Phase 2
Recruiting	`NCT05480228` - EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA	Phase 2
Unknown status	`NCT01125215` - Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy	Phase 2/Phase 3
Not yet recruiting	`NCT05937984` - Treatment for Painful Diabetic Neuropathy	N/A
Recruiting	`NCT05080530` - Vitamin D and Painful Diabetic Neuropathy	N/A
Completed	`NCT04005287` - A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy	Phase 2
Recruiting	`NCT03331614` - An Evaluation of an SCCD on the Symptomatology of Painful DPN	N/A
Recruiting	`NCT03700528` - The Development of Contextual Cognitive Behavioural Approach to PDN	N/A
Recruiting	`NCT04689958` - The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient	Phase 2/Phase 3
Recruiting	`NCT04689984` - The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient	Phase 2/Phase 3
Recruiting	`NCT04689971` - The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient	Phase 2/Phase 3
Completed	`NCT03749642` - Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy	Phase 2
Not yet recruiting	`NCT04087941` - Efficacy and Safety of VM202 in Painful Diabetic Peripheral Neuropathy -The HOPES Trial	Phase 2
Terminated	`NCT01129960` - Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain	Phase 3
Terminated	`NCT01056315` - A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y	Phase 2
Completed	`NCT00980746` - Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy	Phase 2
Completed	`NCT04786340` - A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy	Phase 2
Completed	`NCT03769675` - Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation	N/A
Completed	`NCT03755934` - Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy	Phase 2