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En undersøgelse af NE3107 i tidlig Parkinsons (SUNRISE-PD)

7. august 2026 opdateret af: BioVie Inc.

En dobbeltblind, randomiseret, placebokontrolleret undersøgelse af NE3107 i forsøgspersoner med tidlig Parkinsons sygdom

Målet med dette kliniske forsøg er at finde ud af, om bezisterim kan behandle bevægelsessymptomer på Parkinsons sygdom hos patienter, der er 45 til 80 år gamle, med generelt god fysisk og mental sundhed og nærmer sig behovet for behandling for at lindre deres symptomer, men som ikke har endnu blevet ordineret enhver form for levodopa eller lægemiddel med lignende aktivitet. De vigtigste spørgsmål, den sigter mod at besvare er:

  • Vil bezisterim mindske bevægelsessymptomer på Parkinsons sygdom?
  • Hvilke medicinske problemer har deltagerne, når de tager bezisterim?

Forskere vil sammenligne virkningerne af bezisterim-behandling med placebo (et stof, der ligner hinanden, der ikke indeholder noget lægemiddel) for at se, om bezisterim virker til at behandle bevægelsessymptomer på Parkinsons sygdom.

Deltagerne vil

  • få en fysisk undersøgelse, der inkluderer et elektrokardiogram
  • tage medicin eller placebo to gange dagligt i fire måneder
  • besøge et klinisk sted eller modtage et hjemmebesøg syv gange i løbet af fem måneder

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

57

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Michigan
      • Farmington Hills, Michigan, Forenede Stater, 48334
        • Quest Research Institute
    • New York
      • Amherst, New York, Forenede Stater, 14226
        • Dent Neurologic
    • North Carolina
      • Morrisville, North Carolina, Forenede Stater, 27560
        • Science 37 (Nationwide Site)
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • Neuroscience Research Center, LLC

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • 45 år til 80 år
  • diagnosticeret med idiopatisk Parkinsons sygdom (PD) inden for 18 måneder
  • nærmer sig behovet for symptomatisk behandling
  • accepterer at bruge præventionsmidler
  • give frivilligt samtykke
  • villig til at tillade blodopsamling til DNA-methyleringsanalyse
  • bestå alle screeningstest og procedurer

Ekskluderingskriterier:

  • har taget levodopa eller et andet lignende lægemiddel mod de motoriske symptomer på PD
  • en kendt eller stærkt mistænkt familiær årsag til PD-diagnose
  • større psykisk eller fysisk sygdom
  • sygehistorie med større psykisk eller fysisk sygdom

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
Eksperimentel: NE3107
Forsøgspersoner vil modtage 20 mg NE3107 BID (to gange daglig administration; 40 mg dagligt) som orale kapsler.
Medicin: NE3107
NE3107 20 mg BID
Andre navne:
  • bezisterim
Placebo komparator: Placebo
Forsøgspersonerne vil modtage matchende placebokapsler til oral administration BID (to gange dagligt).
Medicin: Placebo
Placebo BID

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Monocyte Lymphocyte Ratio (MLR)
Tidsramme: 12 Weeks
A unitless inflammatory biomarker calculated by dividing the absolute peripheral blood monocyte count by the absolute peripheral blood lymphocyte count, using values derived from clinical hematology (complete blood count with differential)
12 Weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Systemic Inflammation Response Index (SIRI)
Tidsramme: 12 weeks
A unitless measure of systemic inflammation calculated as the product of the absolute blood neutrophil count and absolute blood monocyte count divided by the absolute blood lymphocyte count in samples obtained for clinical hematology testing.
12 weeks
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Tidsramme: 12 weeks
A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood neutrophil count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
12 weeks
Change in Systemic Immune-Inflammation Index (SII)
Tidsramme: 12 weeks
A unitless composite measure of systemic inflammation and immune status calculated as the product of the absolute peripheral blood platelet count and neutrophil count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
12 weeks
Change in Platelet-to-Lymphocyte Ratio (PLR)
Tidsramme: 12 weeks
A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood platelet count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
12 weeks
Change in Aggregate Index of Systemic Inflammation (AISI)
Tidsramme: 12 weeks
A unitless composite measure of systemic inflammation calculated as the product of the absolute peripheral blood neutrophil count, monocyte count, and platelet count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
12 weeks
Change in the Composite Benefit Score (CBS)
Tidsramme: 12 weeks
Early Parkinson's Neuro-Inflammatory Composite-15 (EPNIC-15), a composite endpoint consisting of 15 clinically relevant motor and non-motor measures derived from MDS-UPDRS Parts I, II, and III and PDSS-2 assessments. Lower scores indicate improvement in Parkinson's disease symptoms.
12 weeks
Change in MDS-UPDRS modified Part III
Tidsramme: 12 weeks
Change from baseline in MDS-UPDRS Modified Part III score, a clinician-rated measure of Parkinson's disease motor signs assessed using a modified Part III examination. The scale evaluates motor manifestations including speech, tremor, rigidity, bradykinesia, gait, posture, and postural stability. Higher scores indicate worse motor impairment.
12 weeks
Change in MDS-UPDRS Part II scores
Tidsramme: 12 weeks
Change from baseline in MDS-UPDRS Part II score. MDS-UPDRS Part II assesses the impact of Parkinson's disease motor symptoms on activities of daily living, with higher scores indicating greater impairment and negative changes indicating improvement.
12 weeks
Change in MDS-UPDRS Part I scores
Tidsramme: 12 weeks
Change from baseline in MDS-UPDRS Part I score. MDS-UPDRS Part I assesses non-motor experiences of daily living in Parkinson's disease, with higher scores indicating greater symptom burden and negative changes indicating improvement.
12 weeks
Change in MDS-UPDRS combined scores
Tidsramme: 12 weeks
Change from baseline in the combined MDS-UPDRS score (Parts I + II + III). The combined score assesses overall Parkinson's disease burden across non-motor symptoms, activities of daily living, and motor signs, with higher scores indicating greater impairment and negative changes indicating improvement.
12 weeks
Change in PDQ-39 score
Tidsramme: 12 weeks
Change from baseline in PDQ-39 total score. The Parkinson's Disease Questionnaire-39 (PDQ-39) assesses health-related quality of life across eight domains affected by Parkinson's disease. Higher scores indicate worse quality of life and negative changes indicate improvement.
12 weeks
Clinician's General Impression of Improvement (CGI-I)
Tidsramme: 12 weeks
Clinician's Global Impression of Improvement (CGI-I) score. The CGI-I is a clinician-rated measure of overall change in a participant's condition compared with baseline, scored on a 7-point scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement.
12 weeks
Clinician's General Impression of Severity (CGI-S)
Tidsramme: 12 weeks
Change from baseline in Clinician's Global Impression of Severity (CGI-S) score. The CGI-S is a clinician-rated measure of overall illness severity scored on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater severity and negative changes indicate improvement.
12 weeks
Change in PARCOMS-Motor (modified to adjust for missing MDS-UPDRS Part III scores)
Tidsramme: 12 weeks
Change from baseline in modified PARCOMS-Motor score. PARCOMS-Motor is a composite measure of Parkinson's disease motor symptoms derived from MDS-UPDRS motor assessments. The score was modified to adjust for missing MDS-UPDRS Part III data. Higher scores indicate greater motor impairment and negative changes indicate improvement
12 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in PDSS-2
Tidsramme: 12 weeks
Change from baseline in PDSS-2 total score. The Parkinson's Disease Sleep Scale-2 (PDSS-2) assesses sleep disturbances and nocturnal symptoms associated with Parkinson's disease. Higher scores indicate worse sleep impairment and negative changes indicate improvement.
12 weeks
Change in DNA methylation
Tidsramme: 12 weeks
Change from baseline in DNA methylation levels measured in peripheral blood samples. DNA methylation is an epigenetic biomarker associated with regulation of gene expression and cellular function.
12 weeks
Percent change in hematologic inflammatory biomarker indices
Tidsramme: 12 weeks
Percent change from baseline in hematologic inflammatory biomarker indices (MLR, NLR, PLR, SIRI, SII, and AISI) derived from routine hematology testing. These indices are calculated from peripheral blood cell counts and are used as measures of systemic inflammation.
12 weeks
Change in plasma biomarkers of inflammation
Tidsramme: 12 week
Change from baseline in plasma biomarkers of inflammation measured in peripheral blood samples. Plasma inflammatory biomarkers are indicators of immune and inflammatory activity that may reflect biological responses to treatment.
12 week
Interaction between baseline inflammation level and treatment effect on changes in circulating inflammatory indices
Tidsramme: 12 weeks
Interaction between baseline inflammation level and treatment effect on changes in circulating inflammatory indices. Analysis of whether treatment effects on MLR, NLR, PLR, SIRI, SII, and AISI vary according to baseline systemic inflammation status.
12 weeks
Interaction between baseline inflammation level and treatment effect on changes in clinical endpoints
Tidsramme: 12 weeks
Interaction between baseline inflammation level and treatment effect on changes in clinical endpoints. Analysis of whether treatment effects on clinical measures vary according to baseline systemic inflammation status.
12 weeks
Interaction between change in inflammation level and treatment effect on changes in circulating inflammatory indices
Tidsramme: 12 week
Relationship between change in inflammation level and change from baseline in circulating inflammatory indices (MLR, NLR, PLR, SIRI, SII, and AISI). Analysis of whether treatment-related changes in systemic inflammation are associated with changes in circulating inflammatory biomarkers.
12 week
Interaction between change in inflammation level and treatment effect on changes in clinical endpoints
Tidsramme: 12 weeks
Relationship between change in inflammation level and change from baseline in clinical endpoints. Analysis of whether treatment-related changes in systemic inflammation are associated with changes in clinical measures of Parkinson's disease.
12 weeks
Percent of subjects with any improvement from baseline as measured by CGI-I
Tidsramme: 12 weeks
Percent of participants with improvement on CGI-I. Improvement is defined as a CGI-I score of 1 (very much improved), 2 (much improved), or 3 (minimally improved). The CGI-I is a clinician-rated measure of overall change from baseline
12 weeks
Percent of subjects with any improvement from baseline as measured by CGI-S
Tidsramme: 12 weeks
Percent of participants with improvement in CGI-S score from baseline. Improvement is defined as any decrease from baseline in the Clinician's Global Impression of Severity (CGI-S) score. The CGI-S is a clinician-rated measure of overall illness severity scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Lower scores indicate less severe illness.
12 weeks
Biological and disease phenotype subgroup analyses for changes in circulating inflammatory biomarker indices
Tidsramme: 12 weeks
Biological and disease phenotype subgroup analyses of changes in circulating inflammatory biomarker indices (MLR, NLR, PLR, SIRI, SII, and AISI). Analyses will evaluate whether treatment-related changes in inflammatory biomarkers differ across predefined biological and disease phenotype subgroups.
12 weeks
Biological and disease phenotype subgroup for changes in clinical endpoints
Tidsramme: 12 weeks
Biological and disease phenotype subgroup analyses of changes in clinical endpoints. Analyses will evaluate whether treatment-related changes in clinical outcome measures differ across predefined biological and disease phenotype subgroups.
12 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

BioVie Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

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)

26. marts 2025

Primær færdiggørelse (Faktiske)

1. maj 2026

Studieafslutning (Faktiske)

31. maj 2026

Datoer for studieregistrering

Først indsendt

24. december 2024

Først indsendt, der opfyldte QC-kriterier

2. januar 2025

Først opslået (Faktiske)

3. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NE3107-PD-202

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

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