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Eligibility
for people ages 21–75
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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

Official Title

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

Details

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.

Keywords

Parkinson's Disease PD EPI-589 EPI589

Eligibility

You can join if…

Open to people ages 21–75

  • Hoehn and Yahr stage ≤ 2.5
  • Ambulatory with or without assistance
  • Agreement to use contraception if within reproductive years
  • Willingness and ability to comply with study procedures
  • Stable regimen of dietary supplements for 30 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 early 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
  • Must not yet require symptomatic medications for PD and not expected to require such treatment before the end of the study
  • 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, LARK2 or other genetic subtype
  • Age 21 to 75 years
  • Stable medication regimen of PD drugs for 30 days (except 60 days for rasagiline)prior to enrollment

You CAN'T join if...

  • 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

    For Idiopathic Subjects

  • Use of any MAO inhibitors, amantadine or other drugs prescribed for core symptoms of Parkinson's disease for idiopathic subjects
  • Use of nortriptyline or fluvoxamine 60 days prior to enrollment

Locations

  • Cedar's Sinai accepting new patients
    Los Angeles, California, 90048, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edison Pharmaceuticals Inc
ID
NCT02462603
Phase
Phase 2
Study Type
Interventional
Last Updated
April 1, 2017
I'm interested in this study!