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Trial record 2 of 2 for:    epi-589

Safety and Biomarker Study of EPI-589 in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02462603
Recruitment Status : Recruiting
First Posted : June 4, 2015
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: EPI-589 Phase 2

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease Subjects
Study Start Date : March 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: EPI-589 500 mg bid
All enrolled subjects will receive treatment with EPI-589
Drug: EPI-589
EPI-589 is a redox active molecule and will be provided in a 250 mg tablet formulation.
Other Name: (R)-Troloxamide quinone

Outcome Measures

Primary Outcome Measures :
  1. Safety as assessed by drug related AEs [ Time Frame: 3 months ]
    Safety as assessed by drug related adverse events

Secondary Outcome Measures :
  1. Biomarker assessments as measured in cerebrospinal fluid, blood and urine [ Time Frame: 3 Months ]
  2. Clinical Disease State as assessed by the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 3 Months ]
  3. Disease morbidity as assessed by composites scales including Non-motor Symptoms Scale (NMSS), PDQ-39 and EQ-5D [ Time Frame: 3 Months ]
  4. Cognitive function as assessed by composite scales including MoCA and DRS-2 scales [ Time Frame: 3 Months ]
  5. Mood as assessed by composite scales including the BDI and MADRS scales [ Time Frame: 3 Months ]
  6. To evaluate changes in pharmacokinetics parameters (cmax) for all treated subjects pre and 3 months post treatment with EPI-589 [ Time Frame: 3 Months ]
  7. Safety as evidenced by development of drug related adverse events after treament with EPI-589 [ Time Frame: 3 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • A confirmed diagnosis of PD plus a genetic diagnosis consistent with PD, specifically PINK1, parkin, LRRK2 or other 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462603

Contact: Matthew B Klein, MD, FACS 650-641-9211 mklein@edisonpharma.com
Contact: Erin P Johnson, BA 650-641-9212 ejohnson@edisonpharma.com

United States, California
Cedar's Sinai Recruiting
Los Angeles, California, United States, 90048
Contact: Michele Tagliati, MD       michele.tagliati@cshs.org   
Contact: Tina Wu, MS    424-315-2870    tina.wux@cshs.org   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Caroline Tanner, MD    415-379-5530    caroline.tanner@ucsf.edu   
Contact: Michael Dodge    415-353-8328    michael.dodge@ucsf.edu   
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: David K Simon, MD, PhD    617-735-3251    dsimon1@bidmc.harvard.edu   
Contact: Althea Silver, MPH, BSN, RN    617-667-9885    asilver2@bidmc.harvard.edu   
Principal Investigator: David K Simon, MD,PhD         
DZNE Site Recruiting
Tuebingen, Germany, 72074
Contact: Thomasd Gasser, MD       thomas.gasser@uni.tuebingen.de   
Contact: Inga Liepelt       inga.liepelt@dzne.de   
United Kingdom
University College of London,Dept. of Clinical Neuroscience Recruiting
London, United Kingdom, NW3 2PF
Contact: Huw Morris, PhD, FRCP    020 7794 0500 ext 36833    h.morris@ucl.ac.uk   
Contact: Vincenzo Libri, MD,PhD, FRCP    +44 (0) 20 3448 4538 ext 4101    vincenzo.libri@ucl.ac.uk   
Sponsors and Collaborators
Edison Pharmaceuticals Inc
Study Director: Matthew B Klein, MD FACS Edison Pharmaceuticals
More Information

Responsible Party: Edison Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT02462603     History of Changes
Other Study ID Numbers: EPI589-15-002
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: June 2017

Keywords provided by Edison Pharmaceuticals Inc:
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases