LY3962681 for Parkinson's (NCT06565195)
Test safety of spinal medication
- Trial ID
- NCT06565195
- Official Title
- A Randomized, Double-blind (Sponsor-unblinded), Placebo-controlled, Single-ascending-dose Study in Healthy Volunteers and a Double-blind (Sponsor-unblinded), Placebo-controlled, Multiple-ascending-dose Study in Patients With Parkinson's Disease to Evaluate the Safety, Tolerability, and PK/PD of LY3962681
- Goal
- Test safety of spinal medication
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Prevail Therapeutics
- Study Type
- INTERVENTIONAL
- Enrollment
- 124 participants
- Conditions
- Parkinson's Disease
- Interventions
- LY3962681, Placebo (aCSF)
Summary For Families
Goal: to find out whether a new experimental medication can be given safely and tolerated, and to learn how it behaves in the body when delivered into the spinal fluid. Approach: healthy volunteers receive a single dose, and people with Parkinson's receive two doses 12 to 24 weeks apart, each time getting either the medication or a placebo of artificial spinal fluid, all given by injection into the spinal fluid. Eligibility: adults 30 to 80; the single-dose part is for otherwise healthy people, while the multiple-dose part is for people with early-stage Parkinson's who meet diagnostic test requirements and are on stable Parkinson's treatments. Follow-up continues for up to about a year after dosing to watch for effects and safety.
Locations
- Austin Clinic PPD, Austin, Texas, United States
- Ehime University Hospital, Tōon, Ehime, Japan
- Oita University Hospital, Yufu, Oita Prefecture, Japan
- P-One Clinic, Keikokai Medical Corporation, Hachiōji, Tokyo, Japan
Frequently Asked Questions
- What is this trial testing?
- This trial is studying LY3962681. Goal: to find out whether a new experimental medication can be given safely and tolerated, and to learn how it behaves in the body when delivered into the spinal fluid. Approach: healthy volunteers receive a single dose, and people with Parkinson's receive two doses 12 to 24 weeks apart, each time getting either the medication or a placebo of artificial spinal fluid, all given by injection into the spinal fluid. Eligibility: adults 30 to 80; the single-dose part is for otherwise healthy people, while the multiple-dose part is for people with early-stage Parkinson's who meet diagnostic test requirements and are on stable Parkinson's treatments. Follow-up continues for up to about a year after dosing to watch for effects and safety.
- Who can participate?
- Participants must be between 30 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 4 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 4 years and 8 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- How many visits does this trial involve?
- SAD: one treatment day with up to 52 weeks follow-up; MAD: two dosing days 12 to 24 weeks apart with follow-up up to 52 weeks after Dose 2.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive). Confirm the full schedule with the study coordinator.