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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. (see Contacts and Locations)
Verified July 2016 by Edison Pharmaceuticals Inc
Sponsor:
Information provided by (Responsible Party):
Edison Pharmaceuticals Inc
ClinicalTrials.gov Identifier:
NCT02462603
First received: May 20, 2015
Last updated: July 12, 2016
Last verified: July 2016
  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: 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 2017
Estimated Primary Completion Date: April 2017 (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

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 ≤ 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

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 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         
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
Study First Received: May 20, 2015
Last Updated: July 12, 2016

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

ClinicalTrials.gov processed this record on March 24, 2017