Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease

Completed · Phase 2

Conditions studied: Parkinson's Disease

In brief

Open-label study with 30-day run-in phase and adaptive design component to include more participants if deemed appropriate by investigators.

Key facts

Study ID

NCT02462603

Run by

Edison Pharmaceuticals Inc

People needed

44

Starts

2016-05-17

Expected to finish

2019-01-08

Last updated by the study team

2022-05-03

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedar's Sinai — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• DZNE Site — Tübingen, Germany
• University College of London,Dept. of Clinical Neuroscience — London, United Kingdom

Full record on ClinicalTrials.gov

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