Shorten daily periods without movement
- 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
- Shorten daily periods without movement
- 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 goal is to see if SER-252 can be given safely and how it behaves in the body while helping shorten the motor OFF periods and unpredictable ON/OFF swings that happen as levodopa wears off. SER-252, called PEOZ-apomorphine, is a new formulation of apomorphine that directly stimulates dopamine receptors to quickly restore movement when dopaminergic tone falls; the trial gives single ascending doses with the enFuse delivery system to measure safety, tolerability and pharmacokinetics, and it is meant to supplement levodopa rather than replace it. The trial is looking for people 40 to 80 years old with idiopathic Parkinson's who show a clear levodopa response, have routine early-morning OFF and at least 2 hours of daily OFF, are on a stable Parkinson medication regimen, have MoCA ≥24, and do not have prior apomorphine or continuous levodopa therapies or certain cardiac or psychiatric conditions.
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 goal is to see if SER-252 can be given safely and how it behaves in the body while helping shorten the motor OFF periods and unpredictable ON/OFF swings that happen as levodopa wears off. SER-252, called PEOZ-apomorphine, is a new formulation of apomorphine that directly stimulates dopamine receptors to quickly restore movement when dopaminergic tone falls; the trial gives single ascending doses with the enFuse delivery system to measure safety, tolerability and pharmacokinetics, and it is meant to supplement levodopa rather than replace it. The trial is looking for people 40 to 80 years old with idiopathic Parkinson's who show a clear levodopa response, have routine early-morning OFF and at least 2 hours of daily OFF, are on a stable Parkinson medication regimen, have MoCA ≥24, and do not have prior apomorphine or continuous levodopa therapies or certain cardiac or psychiatric conditions.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.