A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.
Completed · Phase 1 · Has a placebo group
Conditions studied: Parkinson Disease
In brief
This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with idiopathic PD at the early stage of the disease (modified H\&Y stage ≤2.5) who are either treatment-naïve or on stable treatment with symptomatic therapy (levodopa and/or pramipexole, ropinirole, rotigotine).
Key facts
- Study ID
- NCT05924243
- Run by
- Hoffmann-La Roche
- People needed
- 60
- Starts
- 2022-09-22
- Expected to finish
- 2024-07-18
- Last updated by the study team
- 2024-09-19
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- CenExel Rocky Mountain Clinical Research, LLC — Englewood, Colorado, United States
- Georgetown University — Washington D.C., District of Columbia, United States
- Advent Health Orlando — Orlando, Florida, United States
- Quest Research Institute — Farmington Hills, Michigan, United States
- Weill Cornell Medical College — New York, New York, United States
- The Movement Disorder Clinic of Oklahoma — Tulsa, Oklahoma, United States
- University Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
- Brain Research Center B.V — Amsterdam, Netherlands
- UMC St Radboud — Nijmegen, Netherlands
- Brain Research Center Zwolle — Zwolle, Netherlands
- University of Exeter — Exeter, United Kingdom
- Barts Health NHS Trust — London, United Kingdom
- Imperial College Healthcare NHS Trust; Charing Cross Hospital — London, United Kingdom
- National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRF — London, United Kingdom
- Campus for Ageing & Vitality; Clincal Ageing Research Unit — Newcastle, United Kingdom
Full record on ClinicalTrials.gov
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