Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study) (NCT07142044) | Clinical Trial Compass
RecruitingPhase 1/2
Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
United States18 participantsStarted 2025-11-01
Plain-language summary
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
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult males and females, 50 to 80 years of age (inclusive) at the time of Screening.
. Able to understand the consent form, and to provide voluntary written informed consent.
. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study.
. Confirmed diagnosis of idiopathic Parkinson's Disease according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria.
. Off state Hoehn \& Yahr below Stage 3 at the time of Screening.
. Participants must be on stable doses of L-dopa with or without other adjunctive PD therapy for at least 30 days prior to enrollment. Doses should be expected to remain stable for the duration of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/Phase 2 trial and the primary goal is to measure safety and tolerability of EC5026 rather than prove it works, what does that mean for my personal risk if I were to consider enrolling?
2EC5026 appears to be a relatively early-stage drug being tested in Parkinson's disease — how does what's currently known about it compare to my existing or potential standard-of-care treatment options?
3The trial is actively recruiting right now, so if I were interested, how quickly would I need to make a decision, and what would the time commitment and visit schedule actually look like for someone in my situation?
4Given that the study is measuring both adverse events and serious adverse events as its main outcomes, what kinds of side effects have been seen with EC5026 so far, and are there any that would be especially relevant to my current health status?
5Would participating in this trial affect my ability to use my current Parkinson's medications, or could it limit my options for other treatments if my symptoms change during the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability]
. Participants must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements.
Exclusion criteria
. Participants must have a negative urinary drug screen (UDS) for illicit drugs and a negative alcohol breath test.
0. Abstention from use of other investigative or non-approved drugs for the duration of the trial
1. Male participants who are not surgically sterile (vasectomized) and their female sexual partners must agree to use contraception during the study period and for 2 months after receiving the last dose of study drug.
2. Male participants must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
3. Female participants must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, 'clipping or tying tubes,' or hysterectomy) for at least 3 months, or they must agree to use two forms of highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year) from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after receiving the last dose of study drug. Postmenopausal status will be defined as follows: minimum 1 year; amenorrhea duration of 12 consecutive months and a serum FSH value \>40 IU/L; postmenopausal status must be confirmed by an FSH test at Screening). Highly effective contraception methods include: Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g., Mirena®), and/or barrier methods of contraception, including condoms (external or internal) and diaphragm ('cap'). Hormonal methods of contraception (with the exception of hormonal IUD) are not permitted within this study. Female participants will refrain from using hormonal contraceptives for at least 28 days prior to study entry until the end of the study period. Participants/Participant's partner(s) must also use a barrier form of contraception, from the first dose of study drug through until 2 months after the last dose. For all females of childbearing potential, the pregnancy test result must be negative at Screening and Pre-Study Baseline (Day -1).
4. Participants must be able to speak, read, and understand English sufficiently to allow comprehension and completion of all study assessments.
. Atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs or toxins, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or non-PD degenerative disease).
. Family history of early onset PD (age \<50 years) or known personal genetically causal etiology of PD.