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

Exploration of the Association Between White Matter Lesion Burden and Dalfampridine Response in Insidious-Onset Vascular Parkinsonism (DAL-VaP)

28. juni 2026 opdateret af: Tang-Du Hospital

An Exploratory Cohort Study to Evaluate Whether White Matter Lesion Burden Correlates With Dalfampridine Response in Insidious-Onset Vascular Parkinsonism and Parkinson-Plus Syndromes

This single-center observational cohort study will be conducted at Tangdu Hospital, Fourth Military Medical University. Patients presenting parkinsonism and poor levodopa response will be enrolled, including insidious-onset vascular parkinsonism (VaP) and Parkinson-plus syndromes (PPS). Within each diagnostic subgroup, participants will receive either dalfampridine 10 mg twice daily for 4 weeks combined with conventional therapy, or conventional therapy alone. Change in Timed Up and Go (TUG) time, gait speed, balance, daily function, and quality of life metrics assessed from baseline to Week 4.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Insidious-onset vascular parkinsonism (VaP) is characterized by typical clinical manifestations including gait impairment, postural instability, poor levodopa responsiveness, and diffuse cerebral white matter lesions (WMLs). Dalfampridine is an agent indicated to manage gait dysfunction among patients diagnosed with multiple sclerosis. This study will collect standardized gait and functional scale assessments in participants with insidious-onset VaP and participants with Parkinson-plus syndromes (PPS).

Single-center observational cohort study performed at Tangdu Hospital, Fourth Military Medical University, Xi'an, China. Parkinsonism and poor levodopa response will be divided into two diagnostic subgroups (VaP, PPS). Each subgroup will receive one of two treatment regimens: dalfampridine 10 mg twice daily for 4 weeks plus conventional therapy, or conventional therapy alone.

Change in Timed Up and Go (TUG) test time,10-meter walking speed, Tinetti scale score, ADL scale score, FES-I score, FOG-Q score, and SF-36 summary scores recorded at baseline and Week 4 among participants with VaP.

Baseline white matter lesion volume will be documented as a baseline clinical characteristic of all enrolled participants.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

72

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710038
        • Tangdu Hospital, Fourth Military Medical University

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with insidious-onset vascular parkinsonism or Parkinson-plus syndromes, with gait impairment and poor levodopa response.

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years
  • Clinical diagnosis of insidious-onset vascular parkinsonism or Parkinson-plus syndromes
  • Gait, balance, or mobility impairment
  • Poor levodopa response (<10% improvement in UPDRS-III after levodopa challenge)
  • Ability to complete all study assessments

Exclusion Criteria:

  • Seizure disorder or epilepsy
  • Multiple sclerosis
  • Repeated traumatic brain injury
  • Encephalitis, brain tumor, or normal-pressure hydrocephalus
  • Severe peripheral neuropathy
  • Severe systemic illness or active infection
  • Other neurological/psychiatric conditions interfering with assessments

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
VaP + Dalfampridine
Patients with insidious-onset vascular parkinsonism treated with dalfampridine 10 mg twice daily plus conventional therapy for 4 weeks.
VaP + Conventional Therapy
Patients with insidious-onset vascular parkinsonism treated with conventional therapy alone for 4 weeks.
PPS + Dalfampridine
Patients with Parkinson-plus syndromes treated with dalfampridine 10 mg twice daily plus conventional therapy for 4 weeks.
PPS + Conventional Therapy
Patients with Parkinson-plus syndromes treated with conventional therapy alone for 4 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Timed Up and Go (TUG) Time From Baseline to Week 4
Tidsramme: Baseline to Week 4
Change in the time taken to complete the Timed Up and Go (TUG) test from baseline to Week 4.
Baseline to Week 4

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in 10-Meter Walk Test Speed From Baseline to Week 4
Tidsramme: Baseline to Week 4
Change in speed during the 10-Meter Walk Test from baseline to Week 4.
Baseline to Week 4
Change in Tinetti Balance and Gait Scale Score From Baseline to Week 4
Tidsramme: Baseline to Week 4
Change in total score on the full Tinetti Balance and Gait Scale from baseline to Week 4. The scale ranges from 0 to 28; higher scores indicate superior balance and walking function.
Baseline to Week 4
Change in Activities of Daily Living (ADL) Scale Score From Baseline to Week 4
Tidsramme: Baseline to Week 4
Change in total score on the full Activities of Daily Living (ADL) Scale from baseline to Week 4. Scores range from 0 to 100; higher scores reflect better daily living performance.
Baseline to Week 4
Change in Falls Efficacy Scale-International (FES-I) Score From Baseline to Week 4
Tidsramme: Baseline to Week 4
Change in total score on the full Falls Efficacy Scale-International (FES-I) from baseline to Week 4. Scores range from 16 to 64; higher scores correspond to greater fear of falling.
Baseline to Week 4
Change in Freezing of Gait Questionnaire (FOG-Q) Score From Baseline to Week 4
Tidsramme: Baseline to Week 4
Change in total score on the full Freezing of Gait Questionnaire (FOG-Q) from baseline to Week 4. Scores range from 0 to 24; higher scores mean more severe gait freezing symptoms.
Baseline to Week 4
Change in SF-36 Physical and Mental Component Summary Scores From Baseline to Week 4
Tidsramme: Baseline to Week 4
Change in Physical Component Summary and Mental Component Summary scores on the full SF-36 Health Survey from baseline to Week 4. Each summary score ranges from 0 to 100; higher scores represent better physical or mental health status.
Baseline to Week 4

Samarbejdspartnere og efterforskere

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

Sponsor

Tang-Du Hospital

Efterforskere

  • Ledende efterforsker: Wei Zhang, MD, PhD, Tang-Du Hospital

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. august 2023

Primær færdiggørelse (Faktiske)

31. december 2024

Studieafslutning (Faktiske)

31. januar 2025

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

28. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • K202307-10

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 .

Abonner