EC5026 oral tablet for Parkinson's (NCT07142044)
New medication targets brain inflammation
- Trial ID
- NCT07142044
- Official Title
- Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
- Goal
- New medication targets brain inflammation
- 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
The study wants to know if a new oral medication is safe for people with Parkinson's and whether it reaches and affects the brain pathways it is meant to target, with a secondary look at whether it helps symptoms. The medication blocks an enzyme called soluble epoxide hydrolase, which helps keep natural anti-inflammatory fatty acids active longer in damaged or inflamed brain tissue; participants take the pill every day for 28 days and researchers compare it to a placebo while measuring drug levels in blood and spinal fluid. They are recruiting adults 50 to 80 years old with a confirmed Parkinson's diagnosis who are not in advanced stages, who have been on stable levodopa treatment for at least 30 days, and who can attend frequent clinic visits for blood draws, spinal fluid tests, and questionnaires.
Locations
- University of California Davis, Sacramento, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying EC5026 oral tablet. The study wants to know if a new oral medication is safe for people with Parkinson's and whether it reaches and affects the brain pathways it is meant to target, with a secondary look at whether it helps symptoms. The medication blocks an enzyme called soluble epoxide hydrolase, which helps keep natural anti-inflammatory fatty acids active longer in damaged or inflamed brain tissue; participants take the pill every day for 28 days and researchers compare it to a placebo while measuring drug levels in blood and spinal fluid. They are recruiting adults 50 to 80 years old with a confirmed Parkinson's diagnosis who are not in advanced stages, who have been on stable levodopa treatment for at least 30 days, and who can attend frequent clinic visits for blood draws, spinal fluid tests, and questionnaires.
- 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?
- 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/Phase 2 trial is estimated to last approximately 1 year and 1 month.
- 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 3 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 3 chance (roughly 33%) 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: Blood draw (minimally invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.