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
Plain-Language Summary
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.