Clinical trial • Phase I • Neurology

RO7568282 for Parkinson's disease

Phase I trial of RO7568282 for Parkinson's disease. 140 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Parkinson's disease
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
03-07-2024
First CTIS Authorization Date
27-08-2024

Trial design

Phase I trial across 5 sites in Netherlands.

Target Sample Size
140

Eligibility

Recruits 140 Vulnerable population selected; no details on consent or assent provided..

Vulnerable Population
Vulnerable population selected; no details on consent or assent provided.

Recruitment

Planned Sample Size
140
Recruitment Window Months
42

Geography

Total Number Of Sites
5
Total Number Of Participants
140

Netherlands

Earliest CTIS Part Ii Submission Date
12-08-2024
Latest Decision Or Authorization Date
16-09-2025
Processing Time Days
400
Number Of Sites
5
Number Of Participants
140

Sites

Site Name
Radboud universitair medisch centrum Stichting
Principal Investigator Name
Bas Bloem
Principal Investigator Email
bas.bloem@radboudumc.nl
Contact Person Name
Bas Bloem
Contact Person Email
bas.bloem@radboudumc.nl
Site Name
Pharmaceutical Research Associates Group B.V.
Department Name
Program Management
Principal Investigator Name
Jart Oosterhaven
Principal Investigator Email
Jart.Oosterhaven@iconplc.com
Contact Person Name
Jart Oosterhaven
Contact Person Email
Jart.Oosterhaven@iconplc.com
Site Name
Brain Research Center Zwolle B.V.
Principal Investigator Name
Teus Van Laar
Principal Investigator Email
t.van.laar@umcg.nl
Contact Person Name
Teus Van Laar
Contact Person Email
t.van.laar@umcg.nl
Site Name
Brain Research Center Amsterdam B.V.
Principal Investigator Name
Everart Jort Vijverberg
Principal Investigator Email
j.vijverberg@brainresearchcenter.nl
Contact Person Name
Everart Jort Vijverberg
Site Name
Brain Research Center Den Bosch B.V.
Principal Investigator Name
Gerwin Roks
Principal Investigator Email
g.roks@etz.nl
Contact Person Name
Gerwin Roks
Contact Person Email
g.roks@etz.nl

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
RO7568282

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