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

28 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Vaskulär Parkinsonism

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

Kontakter och platser

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

Studieorter

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

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

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

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

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Change in Timed Up and Go (TUG) Time From Baseline to Week 4 Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Change in 10-Meter Walk Test Speed From Baseline to Week 4 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Tang-Du Hospital

Utredare

Huvudutredare: Wei Zhang, MD, PhD, Tang-Du Hospital

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 augusti 2023

Primärt slutförande (Faktisk)

31 december 2024

Avslutad studie (Faktisk)

31 januari 2025

Studieregistreringsdatum

Först inskickad

8 juni 2026

Först inskickad som uppfyllde QC-kriterierna

28 juni 2026

Första postat (Faktisk)

2 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)