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

Last updated: June 6, 2024
Sponsor: Asklepios Biopharmaceutical, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Parkinson's Disease

Multiple System Atrophy

Dyskinesias

Treatment

This is an observational study.

Clinical Study ID

NCT05699460
ASK-PD-0-CS-001
  • Ages 35-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 imagingabnormalities

  • History of cancer or poorly controlled medical conditions

  • Receiving an investigational drug

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: This is an observational study.
Phase:
Study Start date:
September 29, 2022
Estimated Completion Date:
October 31, 2025

Connect with a study center

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

    Kraków, Lesser Poland Voivodeship
    Poland

    Site Not Available

  • Specjalistyczna Praktyka Lekarska, Prof. Grzegorz Opala

    Katowice,
    Poland

    Site Not Available

  • Mazowiecki Szpital Bródnowski w Warszawie, Oddział Neurologii

    Warszawa,
    Poland

    Site Not Available

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

    Warszawa,
    Poland

    Site Not Available

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Quest Research Institute

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Ohio Health Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • OHSU Parkinson Center & Movement Disorders Program

    Portland, Oregon 97239
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

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