SER-252 for Parkinson's (NCT07422675)
Reduce early morning movement limitations
- Trial ID
- NCT07422675
- Official Title
- A Randomized, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety, Tolerability, and Pharmacokinetics of SER-252 in Patients With Parkinson's Disease and Motor Fluctuations
- Goal
- Reduce early morning movement limitations
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Serina Therapeutics
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- PARKINSON DISEASE (Disorder), Advanced Parkinson's Disease
- Interventions
- SER-252 (PEOZ-apomorphine), enFuse
Summary For Families
The trial is testing a new medication to see if it is safe, tolerable, and how it behaves in the body for people with Parkinson's who have motor fluctuations, meaning times when their usual medicines wear off and movement becomes limited. Participants get one under-the-skin injection of the medication or a placebo, in small groups where later groups receive higher doses and a couple of people are watched first for safety before the rest are dosed; each group has eight people, six getting the drug and two getting placebo. They are looking for people aged 40 to 80 with diagnosed Parkinson's who have routine early-morning OFF periods and at least two hours of OFF time a day, who take levodopa several times daily on a stable schedule and pass basic safety and thinking checks. People who have had continuous levodopa infusions, deep brain stimulation surgery, or who could not tolerate apomorphine in the past are excluded.
Locations
- Rocky Mountain Clinical Research, Englewood, Colorado, United States
- Velocity Clinical Research, Hallandale, Florida, United States
- K2 Medical Research LLC, Maitland, Florida, United States
- Quest Research Institute, Farmington Hills, Michigan, United States
- CMAX, Adelaide, South Australia, Australia
- Monash, Melbourne, Victoria, Australia
Frequently Asked Questions
- What is this trial testing?
- This trial is studying SER-252 (PEOZ-apomorphine). The trial is testing a new medication to see if it is safe, tolerable, and how it behaves in the body for people with Parkinson's who have motor fluctuations, meaning times when their usual medicines wear off and movement becomes limited. Participants get one under-the-skin injection of the medication or a placebo, in small groups where later groups receive higher doses and a couple of people are watched first for safety before the rest are dosed; each group has eight people, six getting the drug and two getting placebo. They are looking for people aged 40 to 80 with diagnosed Parkinson's who have routine early-morning OFF periods and at least two hours of OFF time a day, who take levodopa several times daily on a stable schedule and pass basic safety and thinking checks. People who have had continuous levodopa infusions, deep brain stimulation surgery, or who could not tolerate apomorphine in the past are excluded.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 6 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 1 year.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Injection (minimally invasive). Confirm the full schedule with the study coordinator.