Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

26. september 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

330

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / 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
Medicin: diepalrestat choline
aldose reductase inhibitor
Andre navne:
  • 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
Medicin: diepalrestat choline
aldose reductase inhibitor
Andre navne:
  • BNV-222
Placebo komparator: Group 3
Tablet administered twice daily morning and evening containing placebo
Medicin: Placebo
Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
change from baseline in peroneal motor nerve conduction velocity
Tidsramme: 12 months
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change from baseline in patient-reported Visual Acuity Scales
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 months
conduction velocity measures including median MNCV,
12 months
change in visual acuity compared to baseline
Tidsramme: 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
Tidsramme: 12 months
change from baseline in median F wave latency (MFWL)
12 months
change from baseline in VPT conduction velocity measurement
Tidsramme: 12 months
change from baseline in Vibration Perception Threshold (VPT)
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NeuromaxBionevia

Efterforskere

  • Studieleder: Julia Mockot, MD, NeuroMax Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2014

Primær færdiggørelse (Faktiske)

1. november 2017

Studieafslutning (Faktiske)

1. november 2017

Datoer for studieregistrering

Først indsendt

2. januar 2015

Først indsendt, der opfyldte QC-kriterier

2. januar 2015

Først opslået (Skøn)

6. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NM-ARI-231

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Diabetisk perifer neuropati

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Chile

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner