Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02332005
Other study ID # NM-ARI-231
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date November 2014
Est. completion date November 2017

Study information

Verified date September 2018
Source NeuromaxBionevia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An interventional study to investigate the efficacy and safety of diepalrestat (BNV-222) in diabetic patients with diabetic peripheral neuropathy. Subjects will receive twice daily an oral dose of diepalrestat, an aldose reductase inhibitor, or placebo to investigate the effect on motor nerve conduction velocity (MNCV) and symptomatic clinical responses over 12 months of treatment. Subjects will be assessed at screening and baseline, with office visits every 12 weeks, for a total of 6 visits. The study will explore in a double-blind fashion, the effect of two doses of diepalrestat, 150 and 300 mg, to reduce the loss in nerve conduction velocity that is expected to be demonstrated in the group randomized to placebo treatment for up to 12 months.


Description:

This 12 month double-blind, randomized, placebo-controlled, parallel group efficacy and safety study will enroll 400 adult diabetic subjects with diabetic peripheral neuropathy (DPN) to investigate the effect of diepalrestat (BNV-222) 150 mg, 300 mg, or placebo on MNCV and patients' perception of nerve function over 12 months as measured by VAS scales and composite clinical outcome patient reported scales that evaluate numbness, tingling, cramping, paresthesiae, hyperesthesia, coldness, weakness and spontaneous pain perception of upper and lower extremities, and the effects on other measures of nerve motor and sensory conduction. Subjects will be assessed at screening and baseline, with office visits every 12 weeks, for a total of 6 visits. Subjects will be assessed by testing motor nerve conduction velocity and other assessments at each office visit. A subgroup of 24 patients will be selected for pharmacokinetic (PK) testing for up to 48 hours with additional blood draws on Day 7 and 14. This study will investigate the ability of diepalrestat to reduce the ongoing deterioration of nerve function which is a hallmark of the DPN process.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients with type 1 or type 2 diabetes mellitus that is controlled by oral or parenteral hypoglycemic agents or diet.

- Patients with diabetes that is stable and controlled (HbA1C = than 10 %) with no new symptoms associated with diabetes within previous 3 months.

- Patients diagnosed with neuropathy who have abnormalities in 2 of 3 categories (signs, symptoms, and objective tests of nerve conduction studies or quantitative sensory threshold testing).

- Patients on pain medication (prescribed analgesics), stable for at least 3 months before study entry or pain treatment naive.

- Patients with at least mild painful symptoms of diabetic neuropathy for at least 1 year duration, but not longer than 10 years duration.

- Able to withstand the fundus evaluation during ophthalmology testing

Exclusion Criteria:

- A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure.

- Any neurological disorder that may confound assessment of diabetic peripheral neuropathy such as radiculopathies. multiple sclerosis, myelopathies.

- Ongoing severe peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.

- Neuropathy findings due to any of the following: alcohol abuse, liver or renal disease, toxic exposure, endocrine, metabolic or nutritional disorders, inflammatory diseases, or monoclonal gammopathies.

- Patients with absent peroneal nerve response.

- Other pain that may confound assessment of neuropathic pain.

- Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
diepalrestat choline
aldose reductase inhibitor
Placebo
Placebo

Locations

Country Name City State
Russian Federation Northern State Medical University Arkhangelsk
Russian Federation Health Services Severstal Cherepovets
Russian Federation Clinic of Neurology Ekaterinburg
Russian Federation Kemerovo Regional Clinical Hospital Kemerovo
Russian Federation Central Clinical Hospital No 1 of JSC Russian Railway Moscow
Russian Federation City Clinical Hospital No 50 Moscow
Russian Federation City Clinical Hospital No 71 Moscow
Russian Federation Endocrinology Dispensary Moscow
Russian Federation I M Sechenov First Moscow State Medical University Moscow
Russian Federation IM Sechenov First Moscow State Medical University Moscow
Russian Federation IM Sechenov First Moscow State Medical University Moscow
Russian Federation Morozovskaya Children City Hospital of Moscow Moscow
Russian Federation The Federal Bureau of Medical and Social Expertise Moscow
Russian Federation Perm State Medical Academy Perm
Russian Federation VA Baranov Respublical Hospital Petrozavodsk
Russian Federation Rostov State Medical University Rostov-on-Don
Russian Federation City Polyclinic No 20 Saratov
Russian Federation City Hospital No 40 of the Kurortny District St Petersburg Sestroretsk
Russian Federation City Hospital of the Holy Martyr Elizabeth St Petersburg
Russian Federation Imc Sogaz St Petersburg
Russian Federation Medical Center Reavita St Petersburg
Russian Federation Nikolaev Hospital St Petersburg
Russian Federation Bashkir State Medical University Ufa
Russian Federation Central City Clinical Hospital Ulyanovsk
Russian Federation State Medical University Volgograd
Russian Federation NV Solovyov Clinical Emergency Hospital Yaroslavl
Russian Federation Regional Clinical Hospital Yaroslavl

Sponsors (1)

Lead Sponsor Collaborator
NeuromaxBionevia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary change from baseline in peroneal motor nerve conduction velocity 12 months
Secondary change from baseline in patient-reported Visual Acuity Scales Patients' perception of pain, numbness, tingling, weakness of the foot, ataxia, upper limb symptoms and sensory symptoms assessed by pinprick, light touch, vibration, and temperature 12 months
Secondary change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS) TCNS component measures of symptomatic changes in pain, numbness and other measures 12 months
Secondary change from baseline in quality of life administered by SF-36 instrument patient global impression of quality of life assessed by the SF-36 short form 12 months
Secondary change from baseline in median conduction velocity measurements conduction velocity measures including median MNCV, 12 months
Secondary change in visual acuity compared to baseline Change in visual acuity over 12 months compared to baseline, change in diabetic retinopathy in the dilated eye 12 months
Secondary change from baseline in MFWL conduction velocity measurement change from baseline in median F wave latency (MFWL) 12 months
Secondary change from baseline in VPT conduction velocity measurement change from baseline in Vibration Perception Threshold (VPT) 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04638556 - Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy
Completed NCT05580705 - Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy N/A
Completed NCT02127762 - The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT00835757 - Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy N/A
Recruiting NCT00553592 - Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes Phase 2
Recruiting NCT05863793 - Clinical Study of Acupuncture in the Treatment of Diabetic Peripheral Neuropathy N/A
Withdrawn NCT05041816 - Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy N/A
Recruiting NCT06074562 - A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain Phase 2
Recruiting NCT04457531 - LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy Early Phase 1
Completed NCT02947828 - Polyneuropathy in Diabetes Mellitus Type 2
Completed NCT02056431 - Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy N/A
Completed NCT01681290 - Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes Phase 2
Completed NCT01474772 - Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN) Phase 3
Completed NCT01086150 - Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy Phase 2/Phase 3
Completed NCT03447756 - Titration Study of ABX-1431 Phase 1
Completed NCT04688671 - Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain Phase 2
Completed NCT04984044 - Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms N/A
Completed NCT06130917 - Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN. N/A
Completed NCT01496365 - Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy Phase 2