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NCT06565195 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
A Phase 1 study of Parkinson's Disease, sponsored by Prevail Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
- 4
- Study locations
NCT06565195 is a Phase 1 study of Parkinson's Disease that is actively recruiting participants, run by Prevail Therapeutics. The registered enrollment target is 108 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (83% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT06565195, a Phase 1 study of Parkinson's Disease, is actively recruiting participants, sponsored by Prevail Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid (aCSF), no active drug) given into the spinal fluid. During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered into the spinal fluid. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks post Dose 2.
Conditions Studied
Interventions
- DRUG LY3962681
- OTHER Placebo (aCSF)
Study Locations (4)
Texas
- Austin Clinic PPD - Austin
Ehime
- Ehime University Hospital - Tōon
Oita Prefecture
- Oita University Hospital - Yufu
Tokyo
- P-One Clinic, Keikokai Medical Corporation - Hachiōji
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2024-08-27 |
| Est. Completion | 2029-05-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06565195
The ClinicalTrials.gov registry entry for NCT06565195 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (83% lower). The listed sponsor is Prevail Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which LY3962681 is the first listed.
NCT06565195 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Texas, Ehime, Oita Prefecture.
Frequently Asked Questions
What is clinical trial NCT06565195 about?
NCT06565195 is a clinical study titled "A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease". The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion...
What is the current status of trial NCT06565195?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2024-08-27. Estimated completion is 2029-05-05.
What conditions does trial NCT06565195 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT06565195?
The interventions under investigation include: LY3962681 (DRUG), Placebo (aCSF) (OTHER).
Who is sponsoring clinical trial NCT06565195?
This trial is sponsored by Prevail Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06565195 being conducted?
This trial has 4 study locations across Texas, Ehime, Oita Prefecture, Tokyo. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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