Actively Recruiting
Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
Led by EicOsis Human Health Inc. · Updated on 2025-09-05
18
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
Sponsors
E
EicOsis Human Health Inc.
Lead Sponsor
U
University of California, Davis
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if the oral drug candidate EC5026 is safe and targets the correct pathways to treat Parkinson's Disease in adults. It will also learn about the levels of drug that are achieved in blood and in the fluid surrounding the brain (spinal fluid). The main questions it aims to answer are: * Is EC5026 safe in adults with Parkinson's Disease? * What are the levels of EC5026 achieved after oral administration for 28 days? * What molecules or pathways does EC5026 target, and to what extent? In addition, although it is not one of the primary aims of the study, this clinical trial will also explore if oral administration of EC5026 improves the symptoms of Parkinson's Disease. Researchers will compare EC5026 to a placebo (a look-alike substance that contains no drug). Participants will: * Take EC5026 or a placebo every day for 28 consecutive days * Visit the clinic for frequent checkups, blood tests, spinal fluid tests, and questionnaires
CONDITIONS
Official Title
Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 to 80 years at screening
- Able to understand and provide written informed consent
- Willing and able to comply with all study visits, treatment plans, tests, and procedures
- Confirmed diagnosis of idiopathic Parkinson's Disease by 2015 Movement Disorder Society criteria
- Hoehn & Yahr stage below 3 in off state at screening
- On stable doses of L-dopa with or without adjunctive Parkinson's therapy for at least 30 days before enrollment, expected to remain stable
- Overall stable health based on medical history, physical exam, lab tests, and ECG
- Normal or not clinically significant lab test results including coagulation panel, blood counts, metabolic panel, and creatinine clearance of 60 cm3/min or higher
- Negative drug screen for illicit drugs and negative alcohol breath test
- Abstain from other investigative or non-approved drugs during the trial
- Male participants not surgically sterile and their female partners must use contraception during and 2 months after the study
- Male participants must not donate sperm during and for 12 months after the study
- Female participants must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, surgically sterile for at least 3 months, or use two forms of highly effective contraception from at least 28 days before enrollment until 2 months after the last dose
- Female participants must have negative pregnancy tests at screening and baseline
- Able to speak, read, and understand English sufficiently to complete study assessments
You will not qualify if you...
- Diagnosis of atypical parkinsonian syndrome or secondary parkinsonism
- Family history of early onset Parkinson's Disease (under 50 years) or known genetic cause of Parkinson's Disease
- Any other significant neurological disease that may affect study assessments
- Unstable Parkinson's therapy or likely need for changes in L-dopa during the study
- Presence of Parkinson's psychosis, dementia, or other neuropsychiatric conditions affecting consent or compliance
- Severe dyskinesia interfering with study assessments
- History of neurosurgery for Parkinson's or tremor
- Significant medical, surgical, or lab abnormalities per investigator
- Clinically unstable or significant cardiovascular, renal, liver, respiratory, gastrointestinal, blood, endocrine, or infectious disease including HIV
- Significant abnormalities in screening vital signs, labs, or ECG; poor venous access
- Family history of significant cardiac disease
- Disorders of hypothalamic-pituitary-adrenal or hypothalamic-pituitary-gonadal axes
- Abnormal specific blood hormone levels at screening
- Use of corticosteroids within 12 weeks (topical, oral, IV) or 6 months (intra-articular) before trial or planned use during study
- Use of chemotherapy or history of cancer (except fully excised nonmetastatic skin cancer) within 5 years
- Use or planned use of moderate or strong CYP3A4 inducers or inhibitors within 14 days before or during study
- Use or planned use of CYP3A4 inhibitor dietary aids or supplements (e.g., grapefruit juice) within 14 days before or during study
- Difficulty swallowing oral medications
- Use of investigational drugs within 1 month or 5 half-lives before enrollment
- History of difficult lumbar puncture procedures as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
W
William K Schmidt, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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