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
Plain-Language Summary
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
- Quest Research Institute, Lake Mary, Florida, United States
- Velocity Clinical Research, Durham, North Carolina, 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 4 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.