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12-Month Efficacy and Safety of Diepalrestat in Adults With Diabetic Peripheral Neuropathy, a DB, Placebo-Controlled Study (DE-DPN)

26 september 2018 uppdaterad av: NeuromaxBionevia

Twelve-Month Chronic Efficacy and Safety of Diepalrestat in Adult Subjects With Diabetic Peripheral Neuropathy (DPN), A Randomized, Double-Blind, Placebo-Controlled Study

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

330

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Ryska Federationen
      • Arkhangelsk, Ryska Federationen, 163000
        • Northern State Medical University
      • Cherepovets, Ryska Federationen, 162600
        • Health Services Severstal
      • Ekaterinburg, Ryska Federationen, 620014
        • Clinic of Neurology
      • Kemerovo, Ryska Federationen, 650066
        • Kemerovo Regional Clinical Hospital
      • Moscow, Ryska Federationen, 119034
        • Endocrinology Dispensary
      • Moscow, Ryska Federationen, 119049
        • Morozovskaya Children City Hospital of Moscow
      • Moscow, Ryska Federationen, 119435
        • I M Sechenov First Moscow State Medical University
      • Moscow, Ryska Federationen, 119435
        • IM Sechenov First Moscow State Medical University
      • Moscow, Ryska Federationen, 119991
        • IM Sechenov First Moscow State Medical University
      • Moscow, Ryska Federationen, 121374
        • City Clinical Hospital No 71
      • Moscow, Ryska Federationen, 125367
        • Central Clinical Hospital No 1 of JSC Russian Railway
      • Moscow, Ryska Federationen, 127206
        • City Clinical Hospital No 50
      • Moscow, Ryska Federationen, 127486
        • The Federal Bureau of Medical and Social Expertise
      • Perm, Ryska Federationen, 614107
        • Perm State Medical Academy
      • Petrozavodsk, Ryska Federationen, 185019
        • VA Baranov Respublical Hospital
      • Rostov-on-Don, Ryska Federationen, 344022
        • Rostov State Medical University
      • Saratov, Ryska Federationen, 410053
        • City Polyclinic No 20
      • St Petersburg, Ryska Federationen, 191186
        • Imc Sogaz
      • St Petersburg, Ryska Federationen, 194295
        • Medical Center Reavita
      • St Petersburg, Ryska Federationen, 195257
        • City Hospital of the Holy Martyr Elizabeth
      • St Petersburg, Ryska Federationen, 198510
        • Nikolaev Hospital
      • Ufa, Ryska Federationen, 450000
        • Bashkir State Medical University
      • Ulyanovsk, Ryska Federationen, 432057
        • Central City Clinical Hospital
      • Volgograd, Ryska Federationen, 400131
        • State Medical University
      • Yaroslavl, Ryska Federationen, 150000
        • Regional Clinical Hospital
      • Yaroslavl, Ryska Federationen, 150003
        • NV Solovyov Clinical Emergency Hospital
    • Sestroretsk
      • St Petersburg, Sestroretsk, Ryska Federationen, 197706
        • City Hospital No 40 of the Kurortny District

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Group 1 150 mg
150 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of either 150 mg diepalrestat choline or placebo
Läkemedel: diepalrestat choline
aldose reductase inhibitor
Andra namn:
  • BNV-222
Aktiv komparator: Group 2 300 mg
300 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of 150 mg diepalrestat choline
Läkemedel: diepalrestat choline
aldose reductase inhibitor
Andra namn:
  • BNV-222
Placebo-jämförare: Group 3
Tablet administered twice daily morning and evening containing placebo
Läkemedel: Placebo
Placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
change from baseline in peroneal motor nerve conduction velocity
Tidsram: 12 months
12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
change from baseline in patient-reported Visual Acuity Scales
Tidsram: 12 months
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
change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS)
Tidsram: 12 months
TCNS component measures of symptomatic changes in pain, numbness and other measures
12 months
change from baseline in quality of life administered by SF-36 instrument
Tidsram: 12 months
patient global impression of quality of life assessed by the SF-36 short form
12 months
change from baseline in median conduction velocity measurements
Tidsram: 12 months
conduction velocity measures including median MNCV,
12 months
change in visual acuity compared to baseline
Tidsram: 12 months
Change in visual acuity over 12 months compared to baseline, change in diabetic retinopathy in the dilated eye
12 months
change from baseline in MFWL conduction velocity measurement
Tidsram: 12 months
change from baseline in median F wave latency (MFWL)
12 months
change from baseline in VPT conduction velocity measurement
Tidsram: 12 months
change from baseline in Vibration Perception Threshold (VPT)
12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

NeuromaxBionevia

Utredare

  • Studierektor: Julia Mockot, MD, NeuroMax Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 november 2014

Primärt slutförande (Faktisk)

1 november 2017

Avslutad studie (Faktisk)

1 november 2017

Studieregistreringsdatum

Först inskickad

2 januari 2015

Först inskickad som uppfyllde QC-kriterierna

2 januari 2015

Första postat (Uppskatta)

6 januari 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 september 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 september 2018

Senast verifierad

1 september 2018

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NM-ARI-231

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

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