Slow Parkinson brain cell loss
- Trial ID
- NCT07142044
- Official Title
- Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
- Goal
- Slow Parkinson brain cell loss
- Phase
- PHASE1, PHASE2
- Status
- RECRUITING
- Sponsor
- EicOsis Human Health Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 18 participants
- Conditions
- Parkinson's Disease (PD)
- Interventions
- EC5026 oral tablet, Placebo
Summary For Families
STEP is testing whether EC5026 can be given safely to people with Parkinson's and whether it shows early signs of protecting dopamine neurons and improving symptoms linked to neuroinflammation. EC5026 is an oral tablet thought to modulate pathways that drive inflammation and neuron loss in Parkinson's, it is being compared to placebo and given in addition to participants' stable levodopa regimens so it does not replace existing PD meds. The trial is looking for adults 50 to 80 with confirmed idiopathic Parkinson's, off-state Hoehn and Yahr below Stage 3, who have been on a stable L-dopa dose for at least 30 days and meet routine lab and ECG safety requirements. People with dementia or psychosis, severe dyskinesia, prior PD neurosurgery, significant heart, hormonal, or other unstable medical conditions, recent corticosteroid or certain interacting drug use are excluded.
Locations
- University of California Davis, Sacramento, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying EC5026 oral tablet. STEP is testing whether EC5026 can be given safely to people with Parkinson's and whether it shows early signs of protecting dopamine neurons and improving symptoms linked to neuroinflammation. EC5026 is an oral tablet thought to modulate pathways that drive inflammation and neuron loss in Parkinson's, it is being compared to placebo and given in addition to participants' stable levodopa regimens so it does not replace existing PD meds. The trial is looking for adults 50 to 80 with confirmed idiopathic Parkinson's, off-state Hoehn and Yahr below Stage 3, who have been on a stable L-dopa dose for at least 30 days and meet routine lab and ECG safety requirements. People with dementia or psychosis, severe dyskinesia, prior PD neurosurgery, significant heart, hormonal, or other unstable medical conditions, recent corticosteroid or certain interacting drug use are excluded.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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/Phase 2 trial is estimated to last approximately 1 year and 2 months.
- 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.