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Trial record 2 of 2 for:    epi-589

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

This study is currently recruiting participants.
Verified June 2017 by Edison Pharmaceuticals Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02462603
First Posted: June 4, 2015
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Edison Pharmaceuticals Inc
  Purpose
Open-label study with 30-day run-in phase and adaptive design component to include more subjects if deemed appropriate by investigators.

Condition Intervention Phase
Parkinson's Disease Drug: EPI-589 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Edison Pharmaceuticals Inc:

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


Secondary Outcome Measures:
  • Biomarker assessments as measured in cerebrospinal fluid, blood and urine [ Time Frame: 3 Months ]
  • 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 ]
  • Disease morbidity as assessed by composites scales including Non-motor Symptoms Scale (NMSS), PDQ-39 and EQ-5D [ Time Frame: 3 Months ]
  • Cognitive function as assessed by composite scales including MoCA and DRS-2 scales [ Time Frame: 3 Months ]
  • Mood as assessed by composite scales including the BDI and MADRS scales [ Time Frame: 3 Months ]
  • To evaluate changes in pharmacokinetics parameters (cmax) for all treated subjects pre and 3 months post treatment with EPI-589 [ Time Frame: 3 Months ]
  • Safety as evidenced by development of drug related adverse events after treament with EPI-589 [ Time Frame: 3 Months ]

Estimated Enrollment: 40
Study Start Date: March 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


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

Locations
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         
Germany
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
Investigators
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 Submitted: May 20, 2015
First Posted: June 4, 2015
Last Update Posted: July 2, 2017
Last Verified: June 2017

Keywords provided by Edison Pharmaceuticals Inc:
Parkinson's Disease
PD
EPI-589
EPI589

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