Vascular ParkinsonismDAL-VaPNCT07682428
Exploration of the Association Between White Matter Lesion Burden and Dalfampridine Response in Insidious-Onset Vascular Parkinsonism
An observational study of Vascular Parkinsonism, run by Tang-Du Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vascular Parkinsonism
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with insidious-onset vascular parkinsonism or Parkinson-plus syndromes, with gait impairment and poor levodopa response.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Tangdu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710038
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Vascular Parkinsonism
- Keywords
- Vascular parkinsonism; Dalfampridine; Parkinson-plus syndromes; Gait impairment; White matter lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 4
Secondary outcomes (6)
Change in 10-Meter Walk Test Speed From Baseline to Week 4
Change in speed during the 10-Meter Walk Test from baseline to Week 4.
Measured: Baseline to Week 4
Change in Tinetti Balance and Gait Scale Score From 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.
Measured: Baseline to Week 4
Change in Activities of Daily Living (ADL) Scale Score From 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.
Measured: Baseline to Week 4
Change in Falls Efficacy Scale-International (FES-I) Score From 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.
Measured: Baseline to Week 4
Change in Freezing of Gait Questionnaire (FOG-Q) Score From 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.
Measured: Baseline to Week 4
Change in SF-36 Physical and Mental Component Summary Scores From 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.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Aug 2023
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ParkinsonismStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Zhang, MD, PhD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682428
- Sponsor's protocol ID
- K202307-10
- Acronym
- DAL-VaP
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Cohort Study to Evaluate Whether White Matter Lesion Burden Correlates With Dalfampridine Response in Insidious-Onset Vascular Parkinsonism and Parkinson-Plus Syndromes
- ClinicalTrials.gov ID
- NCT07682428
- Acronym / sponsor ID
- DAL-VaP / K202307-10
- Conditions
- Vascular Parkinsonism
- Keywords
- Vascular parkinsonism; Dalfampridine; Parkinson-plus syndromes; Gait impairment; White matter lesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with insidious-onset vascular parkinsonism or Parkinson-plus syndromes, with gait impairment and poor levodopa response.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Seizure disorder or epilepsy
- Multiple sclerosis
- Repeated traumatic brain injury
- Encephalitis, brain tumor, or normal-pressure hydrocephalus
- Severe peripheral neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Timed Up and Go (TUG) Time From Baseline to Week 4
Time frame: Baseline to Week 4
Change in the time taken to complete the Timed Up and Go (TUG) test from baseline to Week 4.
6 secondary outcomes
Change in 10-Meter Walk Test Speed From Baseline to Week 4
Time frame: Baseline to Week 4
Change in Tinetti Balance and Gait Scale Score From Baseline to Week 4
Time frame: Baseline to Week 4
Change in Activities of Daily Living (ADL) Scale Score From Baseline to Week 4
Time frame: Baseline to Week 4
Change in Falls Efficacy Scale-International (FES-I) Score From Baseline to Week 4
Time frame: Baseline to Week 4
Change in Freezing of Gait Questionnaire (FOG-Q) Score From Baseline to Week 4
Time frame: Baseline to Week 4
Change in SF-36 Physical and Mental Component Summary Scores From Baseline to Week 4
Time frame: Baseline to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhang, MD, PhD principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Parkinsonism, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Timed Up and Go (TUG) Time From Baseline to Week 4 (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.