Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy

NCT ID: NCT05699460

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-29

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease Multiple System Atrophy, Parkinson Variant Multiple System Atrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early Parkinson's disease

This is an observational study.

Intervention Type OTHER

This is an observational study.

Possible or Probable MSA-P

This is an observational study.

Intervention Type OTHER

This is an observational study.

Interventions

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This is an observational study.

This is an observational study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AskBio Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California Irvine

Irvine, California, United States

Site Status

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Quest Research Institute

Farmington Hills, Michigan, United States

Site Status

Ohio Health Research Institute

Columbus, Ohio, United States

Site Status

OHSU Parkinson Center & Movement Disorders Program

Portland, Oregon, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Zespol Poradni Specjalistycznych - Botaniczna 3 Poradnia Neurologiczna Szpital Uniwersytecki w Krakowie

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala

Katowice, , Poland

Site Status

Mazowiecki Szpital Bródnowski w Warszawie, Oddział Neurologii

Warsaw, , Poland

Site Status

Samodzielny Publiczny Szpital Kliniczny im. prof. Witolda Orłowskiego, Oddział Neurologii i Epileptologii

Warsaw, , Poland

Site Status

Countries

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United States Poland

Other Identifiers

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ASK-PD-0-CS-001

Identifier Type: -

Identifier Source: org_study_id

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