Loading clinical trials...

Safety and Biomarker Study of PTC-589 in Participants With Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease Subjects

NCT02462603•Edison Pharmaceuticals Inc

Summary

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

Detailed Description

This is a within-subject, controlled open-label study seeking to determine if PTC-589 can alter the biochemical signature of Parkinson's disease as assessed by peripheral blood biomarkers, central nervous system (CNS) biomarkers, and urine biomarker analysis. In addition, data on a number of disease-relevant clinical measures will be collected.

Eligibility

Age

21 - 75 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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
+5 more criteria

Locations (5)

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

Key Dates

Start Date

May 17, 2016

Primary Completion Date

January 8, 2019

Completion Date

January 8, 2019

Last Updated

May 3, 2022

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

PTC-589

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

View study

RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations