Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease (NCT02462603) | Clinical Trial Compass
CompletedPhase 2
Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease
United States, Germany, United Kingdom44 participantsStarted 2016-05-17
Plain-language summary
Open-label study with 30-day run-in phase and adaptive design component to include more participants if deemed appropriate by investigators.
Who can participate
Age range21 Years – 75 Years
SexALL
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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, sp…
What they're measuring
1
Number of Participants With Drug-Related Serious Adverse Events (SAEs)
Timeframe: Baseline up to 30 days after last dose of study drug (up to 4 months)