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 range

21 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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)

Trial details

NCT IDNCT02462603

SponsorEdison Pharmaceuticals Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-01-08

Results submitted2022-04-06

View on ClinicalTrials.gov More Parkinson's Disease trials

Who can participate

Age range

21 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.