Parkinson's DiseaseNCT05699460
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
An observational study of Parkinson's Disease and Multiple System Atrophy, Parkinson Variant, run by AskBio Inc at 11 sites in 2 countries.
Trial summary
The objective of this study is to describe disease progression in study participants diagnosed with early Parkinson's Disease or Multiple System Atrophy - Parkinsonian Type up to 18 months as delineated by clinical and biochemical parameters. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy, Parkinson Variant, Multiple System Atrophy
- What is being tested?
- This is an observational study.
- How many people
- 73 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 29 Sep 2022to 4 Nov 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will have a diagnosis of early Parkinson's disease OR possible or probably MSA-P
Who may be able to join
- Diagnosis of Idiopathic PD
- Diagnosis of MSA-P
- One to six years from clinical diagnosis of PD
- Less than 4 years from clinical diagnosis of MSA with expected survival >3 years
- Stable medication regimen
- Ability to walk with or without an assistive device
Who cannot join
- Movement disorder due to known cerebrovascular disease, brain tumor, trauma, exposure to parkinsonian-linked toxicants or other neurological diseases
- Presence of dementia, psychosis, substance abuse or poorly controlled depression
- Prior brain surgery (i.e. deep brain stimulation) or other brain imaging abnormalities
- History of cancer or poorly controlled medical conditions
- Receiving an investigational drug
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States7 sites
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ohio Health Research Institute
Columbus, Ohio, 43214
Quest Research Institute
Farmington Hills, Michigan, 48334
University of California Irvine
Irvine, California, 92697
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
OHSU Parkinson Center & Movement Disorders Program
Portland, Oregon, 97239
Poland4 sites
Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala
Katowice
Zespol Poradni Specjalistycznych - Botaniczna 3 Poradnia Neurologiczna Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship
Mazowiecki Szpital Bródnowski w Warszawie, Oddział Neurologii
Warsaw
Samodzielny Publiczny Szpital Kliniczny im. prof. Witolda Orłowskiego, Oddział Neurologii i Epileptologii
Warsaw
About this study
Official title: A Pre-Gene Therapy Study of Early Parkinson's or Multiple System Atrophy Progression by Longitudinal Clinical and Biomarker Assessments
The objective of this study is to describe disease progression in study participants diagnosed with early Parkinson's Disease or Multiple System Atrophy - Parkinsonian Type up to 18 months as delineated by clinical and biochemical parameters.
- Being tested
- This is an observational study.
- Keywords
- MSA, MSA-P, PD, Observational, Natural History
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study.Other
This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Early Parkinson's disease | Not described Receives: Other: This is an observational study. | |
| Possible or Probable MSA-P | Not described Receives: Other: This is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor symptoms as assessed by the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change from baseline in the MDS-UPDRS. The MDS-UPDRS contains 4 subscales: Part I, non-motor aspects of experiences of daily living (13 items); Part II, motor aspects of experiences of daily living (13 items); Part III, motor examination (33 scores based on 18 items); Part IV, motor complications (6 items). The rating for each item, or sub-item, is from 0 (normal) to 4 (severe). The total score for each Part is obtained from the sum of the corresponding item scores.
Measured: 18 months
MSA symptoms/signs as assessed by the Unified Multiple System Atrophy Rating Scale (UMSARS)
Change from baseline in the Unified Multiple System Atrophy Rating Scale (UMSARS) and compared to placebo. UMSARS total scores range from 0-104 points with higher scores indicating greater severity of impairment.
Measured: 18 Months
Secondary outcomes (2)
Change in the quality of life as measured by Parkinson's Disease Questionnaire (PDQ-39)
Change from baseline in the Parkinson's Disease Questionnaire (PDQ-39). PDQ-39 is a self-reported 39-item questionnaire designed to measure health related quality of life in Parkinson's Disease patients. It provides scores in 8 domains: mobility, activities of daily living, emotions, stigma, social support, cognitive function, bodily discomfort and communication, as well as a summary index score for quality of life.
Measured: 18 months
Change in the quality of life as measured by Multiple System Atrophy Quality of Life (MSA-QoL)
Change from baseline in the Multiple System Atrophy Quality of Life (MSA-QoL) scale. MSA-QoL is a self-reported questionnaire that measures MSA impact in day to day activities. Scale consists of 40 items with a five response option format (0 - no problem to 4 extreme problem) and a "not applicable" response option.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start29 Sep 2022
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- AskBio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699460
- Sponsor's protocol ID
- ASK-PD-0-CS-001
- Status last verified
- Jul 2026
- First submitted
- 13 Oct 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-Gene Therapy Study of Early Parkinson's or Multiple System Atrophy Progression by Longitudinal Clinical and Biomarker Assessments
- ClinicalTrials.gov ID
- NCT05699460
- Acronym / sponsor ID
- ASK-PD-0-CS-001
- Keywords
- MSA, MSA-P, PD, Observational, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- AskBio IncIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 26 Jan 2023 (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.
The objective of this study is to describe disease progression in study participants diagnosed with early Parkinson's Disease or Multiple System Atrophy - Parkinsonian Type up to 18 months as delineated by clinical and biochemical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Parkinson's disease | – | Other: This is an observational study. |
| Possible or Probable MSA-P | – | Other: This is an observational study. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will have a diagnosis of early Parkinson's disease OR possible or probably MSA-P
Key inclusion criteria (6 listed)
- Diagnosis of Idiopathic PD
- Diagnosis of MSA-P
- One to six years from clinical diagnosis of PD
- Less than 4 years from clinical diagnosis of MSA with expected survival >3 years
- Stable medication regimen
Key exclusion criteria (6 listed)
- Movement disorder due to known cerebrovascular disease, brain tumor, trauma, exposure to parkinsonian-linked toxicants or other neurological diseases
- Presence of dementia, psychosis, substance abuse or poorly controlled depression
- Prior brain surgery (i.e. deep brain stimulation) or other brain imaging abnormalities
- History of cancer or poorly controlled medical conditions
- Receiving an investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational study.This is an observational study. | Other | Early Parkinson's disease, Possible or Probable MSA-P |
Primary outcome
Motor symptoms as assessed by the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 18 months
Change from baseline in the MDS-UPDRS. The MDS-UPDRS contains 4 subscales: Part I, non-motor aspects of experiences of daily living (13 items); Part II, motor aspects of experiences of daily living (13 items); Part III, motor examination (33 scores based on 18 items); Part IV, motor complications (6 items). The rating for each item, or sub-item, is from 0 (normal) to 4 (severe). The total score for each Part is obtained from the sum of the corresponding item scores.
MSA symptoms/signs as assessed by the Unified Multiple System Atrophy Rating Scale (UMSARS)
Time frame: 18 Months
Change from baseline in the Unified Multiple System Atrophy Rating Scale (UMSARS) and compared to placebo. UMSARS total scores range from 0-104 points with higher scores indicating greater severity of impairment.
2 secondary outcomes
Change in the quality of life as measured by Parkinson's Disease Questionnaire (PDQ-39)
Time frame: 18 months
Change in the quality of life as measured by Multiple System Atrophy Quality of Life (MSA-QoL)
Time frame: 18 months
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 27 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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Multiple System Atrophy, Parkinson Variant, run by AskBio Inc at 11 sites in 2 countries.
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 6 inclusion and 6 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 27 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 11 sites in United States, Poland. 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?
Motor symptoms as assessed by the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: 18 months). The study lists 2 primary outcomes in all. 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 27 Jul 2026.