A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
LY3962681: IT injection
Placebo (aCSF): IT injection
Study summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in healthy volunteers and patients with Parkinson's disease.
The study consists of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Dose (MAD) study.
During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid \[aCSF\]) administered intrathecally (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 intrathecally (into the spinal fluid), 12 to 24 weeks apart.
* The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 dosing 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 after Dose 2.
Eligibility
Primary outcome measure(s)
- Incidence of Serious Adverse Events (SAEs) — Up to 76 weeks
- Incidence of Treatment Emergent Adverse Events (TEAEs) — Up to 76 weeks
- Number of discontinuations due to Adverse Events (AEs) — Up to 76 weeks
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| CenExel | Englewood | Colorado | Not Yet Recruiting |
| XingImaging LLC | New Haven | Connecticut | Not Yet Recruiting |
| Aqualane Clinical Research | Naples | Florida | Recruiting |
| Northwestern University Feinberg School of Medicine Dept of Neurology | Chicago | Illinois | Not Yet Recruiting |
| Quest Research Institute - Alcanza | Farmington Hills | Michigan | Recruiting |
| University of Pennsylvania, Dept of Neurology | Philadelphia | Pennsylvania | Not Yet Recruiting |
| Austin Clinic PPD | Austin | Texas | Completed |
| Universitätsklinikum Düsseldorf | Düsseldorf | North Rhine-Westphalia | Not Yet Recruiting |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | Not Yet Recruiting |
| Ehime University Hospital | Tōon | Ehime | Recruiting |
| Oita University Hospital | Yufu | Oita Prefecture | Not Yet Recruiting |
| P-One Clinic, Keikokai Medical Corporation | Hachiōji | Tokyo | Recruiting |
| Radboud Universitair Medisch Centrum | Nijmegen | Gelderland | Not Yet Recruiting |
| CTC Netherlands BV | Groningen | Provincie Groningen | Not Yet Recruiting |
| Southampton General Hospital, NHS Trust | Southampton | Hampshire | Not Yet Recruiting |
| John Radcliffe Hospital | Oxford | Oxfordshire | Not Yet Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06565195 on ClinicalTrials.gov ↗ ← All trials in the Netherlands