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Tests treatment safety and results for Parkinson's Disease (PD)
Official title Safety, Tolerability and Exploratory Efficacy of EC5026 in Parkinson's Disease (STEP Study)
ClinicalTrials.gov ID: NCT07142044
What this study is testing
What is EC5026 oral tablet?
EC5026 oral tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for parkinson's disease (pd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- 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.
You likely can't join if
- per se.
- Participants must have a negative urinary drug screen (UDS) for illicit drugs and a negative alcohol breath test.
- Abstention from use of other investigative or non-approved drugs for the duration of the trial
- Male participants who are not surgically sterile (vasectomized) and their female sexual partners must agree to use contraception during the study...
- Male participants must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
- Female participants must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal...
See the full eligibility criteria
Who can join
- 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.
- Participants must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements.
- Participants must have normal or not clinically significant clinical laboratory test results, as determined by the study investigator, including coagulation panel, blood cell counts, comprehensive metabolic panel...
What rules you out
- per se.
- Participants must have a negative urinary drug screen (UDS) for illicit drugs and a negative alcohol breath test.
- Abstention from use of other investigative or non-approved drugs for the duration of the trial
- 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.
- Male participants must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
- 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...
- Participants must be able to speak, read, and understand English sufficiently to allow comprehension and completion of all study assessments. Exclusion Criteria:
- 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.
- Diagnosis of any other clinically significant neurologic disease that may confound the assessment of the study drug on PD symptoms
- Not stabilized with current therapeutic regimen for PD or likely to require changes in L-dopa therapy over the duration of the trial.
- Presence of PD psychosis or dementia, or other neuropsychiatric or psychiatric conditions impeding informed consent or compliance with study interventions.
- Severe dyskinesia (defined as per MDS-UPDRS) during a "normal day" that would significantly interfere with the participant's ability to perform study assessments.
- History of neurosurgery for PD or tremor.
- Clinically significant medical, surgical, or laboratory abnormalities in the judgement of the Investigator.
- Participants with any clinically unstable or significant cardiovascular (including acute coronary syndrome within the prior year to Screening), renal, hepatic, respiratory, gastrointestinal, hematological, endocrine, or...
- Participants with clinically significant abnormalities on screening vital signs, laboratory tests, and/or ECG, per investigator's judgement. Participants with poor venous access will also be excluded.
- Participants with a family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction before the age of 50).
- Participants with a history of disorders of the hypothalamic-pituitary-adrenal axis, including adrenal insufficiency and Cushing's, or with a history of disorders of the hypothalamic-pituitary-gonadal axis, including...
- Participants with any of the following blood values at screening:
- Abnormal plasma renin and/or aldosterone value
- Morning cortisol level \<5 mcg/dL
- ACTH stimulated cortisol levels \<18 mcg/dL at 60 minutes after ACTH injection at screening, or
- Abnormal FSH, LH, testosterone (for males), or estradiol (for females, unless post-menopausal)
- Participants who have used any topical, oral, or intravenous exogenous corticosteroids within 12 weeks and/or intra-articular exogenous corticosteroids within 6 months prior to the start of the trial, or who plan on...
- Participants who have used chemotherapy agents, or who have a personal history of cancer or cancer in first degree relatives suggestive of elevated cancer risk, other than nonmetastatic skin cancer that has been...
- Participants who have used (within 14 days of randomization) or plan on using during the duration of the study any prescription or over-the-counter drugs that are moderate or strong CYP3A4 inducers or inhibitors.
- Participants who have used (within 14 days of randomization) or plan on using during the duration of the study any dietary aids, supplements, or foods that are moderate or strong CYP3A4 inhibitors (e.g., grapefruit...
- Participants with difficulty in swallowing oral medications
- Participants who have used any other investigational drug within 1 month or 5 half-lives, whichever is longer, prior to enrollment.
- Participants with a documented history of difficult lumbar puncture procedures, to the investigator's discretion.
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.