Clinical trial • Phase I • Neurology
LY3962681 for Parkinson's disease
Phase I trial of LY3962681 for Parkinson's disease. Randomised, placebo (matching placebo), dose and schedule not specified.-controlled, adaptive.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Parkinson's disease
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 27-11-2024
- First CTIS Authorization Date
- 01-04-2025
Trial design
Randomised, placebo (matching placebo), dose and schedule not specified.-controlled, adaptive Phase I trial across 5 sites in Germany, Netherlands.
- Randomised
- Yes
- Comparator
- Placebo (matching placebo), dose and schedule not specified.
- Adaptive
- True, single-ascending-dose and multiple-ascending-dose (dose-escalation) design; no detailed dose escalation rules, interim analyses, or stopping rules provided.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 98
Eligibility
Recruits 98 No vulnerable populations selected; no information provided on consent or assent..
- Vulnerable Population
- No vulnerable populations selected; no information provided on consent or assent.
Recruitment
- Planned Sample Size
- 98
- Recruitment Window Months
- 49
- Consent Approach
- No information provided on informed consent or assent; vulnerable populations not selected.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 10
Germany
- Earliest CTIS Part Ii Submission Date
- 12-03-2025
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 370
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Zentrum für Bewegungsstörungen und Neuromodulation
- Principal Investigator Name
- Alfons Schnitzler
- Principal Investigator Email
- schnitza@med.uni-duesseldorf.de
- Contact Person Name
- Alfons Schnitzler
- Contact Person Email
- schnitza@med.uni-duesseldorf.de
- Site Name
- Universitaet Muenster
- Department Name
- Klinik für Neurologie mit Institut für Translationale Neurologie
- Principal Investigator Name
- Inga Claus
- Principal Investigator Email
- inga.claus@ukmuenster.de
- Contact Person Name
- Inga Claus
- Contact Person Email
- inga.claus@ukmuenster.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Neurologie
- Principal Investigator Name
- Thomas Gasser
- Principal Investigator Email
- thomas.gasser@uni-tuebingen.de
- Contact Person Name
- Thomas Gasser
- Contact Person Email
- thomas.gasser@uni-tuebingen.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 07-03-2025
- Latest Decision Or Authorization Date
- 19-03-2026
- Processing Time Days
- 377
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Neurological Movement Disorders
- 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
- CTC Netherlands BV
- Department Name
- Neurology
- Principal Investigator Name
- Khalid Abd-Elaziz
- Principal Investigator Email
- khalid.abdelaziz@ctc-netherlands.com
- Contact Person Name
- Khalid Abd-Elaziz
- Contact Person Email
- khalid.abdelaziz@ctc-netherlands.com
Sponsor
Primary sponsor
- Full Name
- Prevail Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- LY3962681
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