Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02462603
Eligibility Criteria:
Inclusion Criteria:
* Hoehn and Yahr stage ≤3.0
* Ambulatory with or without assistance
* Sexually active fertile participants and their partners must agree to use medically accepted methods of contraception (such as, hormonal methods, including oral, subcutaneous, and intrauterine; barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the last dose of study treatment.
* Willingness and ability to comply with study procedures
* If on medications for Parkinson's disease drugs, then medication regimen must be stable for 60 days prior to enrollment
* Abstention from use of other investigative or non-approved drugs for the duration of the trial
For Idiopathic Participants
* A diagnosis of idiopathic Parkinson's disease confirmed by the presence of bradykinesia plus one or both of the following symptoms: rigidity or resting tremor; and with an abnormal DaTscan consistent with a dopaminergic deficit
* Age 40 to 75 years
* Within 5 years of diagnosis of Parkinson's disease
For Genetic Subtype Participants
* A confirmed diagnosis of Parkinson's disease plus a genetic diagnosis consistent with Parkinson's disease, specifically PTEN-induced kinase 1 (PINK1), parkin, Leucine-rich repeat kinase 2 (LRRK2) or other mitochondrial genetic subtype
* Age 21 to 75 years
Exclusion Criteria:
* Allergy to PTC-589 or other components of the PTC-589 tablet formulation
* Use of antioxidant supplements, specifically vitamins E and C beyond the recommended daily allowance
* Other Parkinsonian disorders
* Montreal Cognitive Assessment (MoCA) score of \<24
* Revised Hamilton Rating Scale for Depression ≥11
* Parkinsonism due to drugs or toxins
* Diagnosis of any other clinically significant neurologic disease that will confound the assessment of effect of study drug on disease progression
* Malignancy within past 2 years
* Pregnant or plans to become pregnant or breast feeding
* History of stroke
* History of brain surgery
* Hepatic insufficiency with liver function tests (LFTs) \>3 times upper limit of normal
* Renal insufficiency as defined by creatinine \>1.5 times normal
* End stage cardiac failure
* Participation within past 3 months and for duration of study in a trial of a device, drug, or other therapy for Parkinson's disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT02462603
Study Brief:
Protocol Section:
NCT02462603