Expired Study
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San Francisco, California 94115


Purpose:

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


Study summary:

This is a within-subject, controlled open-label study seeking to determine if EPI-589 can alter the biochemical signature of PD as assessed by peripheral blood and brain imaging biomarkers. Data will also be collected on disease-relevant clinical measures will be collected.


Criteria:

Inclusion Criteria: - Hoehn and Yahr stage ≤ 3.0 - Ambulatory with or without assistance - Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., 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 PD drugs, then medication regimen must be stable for 60 days prior to enrollment - Abstention from use of other investigative or nonapproved drugs for the duration of the trial. For Idiopathic Subjects - A diagnosis of idiopathic PD 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 Subjects - A confirmed diagnosis of PD plus a genetic diagnosis consistent with PD, specifically PINK1, parkin, LRRK2 or other mitochondrial genetic subtype - Age 21 to 75 years Exclusion Criteria: - Allergy to EPI-589 or other components of the EPI-589 tablet formulation - Use of antioxidant supplements, specifically vitamins E and C beyond the recommended daily allowance - Other Parkinsonian disorders - 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 two 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 PD


NCT ID:

NCT02462603


Primary Contact:

Study Director
Matthew B Klein, MD FACS
Edison Pharmaceuticals


Backup Contact:

N/A


Location Contact:

San Francisco, California 94115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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