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

NCT07682428 | Completed

• 1 other identifier: K202307-10
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Parkinsonism

Keywords

Vascular parkinsonism; Dalfampridine; Parkinson-plus syndromes; Gait impairment; White matter lesions

Outcome Measures

Primary Outcomes (1)

• Change in Timed Up and Go (TUG) Time From 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

Secondary Outcomes (6)

• Change in 10-Meter Walk Test Speed From Baseline to Week 4

  Baseline to Week 4

• Change in Tinetti Balance and Gait Scale Score From Baseline to Week 4

  Baseline to Week 4

• Change in Activities of Daily Living (ADL) Scale Score From Baseline to Week 4

  Baseline to Week 4

• Change in Falls Efficacy Scale-International (FES-I) Score From Baseline to Week 4

  Baseline to Week 4

• Change in Freezing of Gait Questionnaire (FOG-Q) Score From Baseline to Week 4

  Baseline to Week 4

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710038, China

Location

Study Officials

• Wei Zhang, MD, PhD

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: July 2, 2026
• Study Start: August 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)