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    Summary
    EudraCT Number:2015-001786-10
    Sponsor's Protocol Code Number:EPI589-15-002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2015-001786-10
    A.3Full title of the trial
    A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease.
    A.3.2Name or abbreviated title of the trial where available
    Safety and Biomarker Study with EPI-589 in Parkinson's Disease
    A.4.1Sponsor's protocol code numberEPI589-15-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02462603
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)
    B.5.2Functional name of contact pointBioElectron info e-mail address
    B.5.3 Address:
    B.5.3.1Street Address350 North Bernardo Ave
    B.5.3.2Town/ cityMountain View CA
    B.5.3.3Post code94043
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016506419200
    B.5.6E-mailinfo@bioelectron.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEPI-589
    D.3.2Product code EPI-589
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKinoquinone (proposed)
    D.3.9.1CAS number 1147883-03-1
    D.3.9.2Current sponsor codeEPI-589
    D.3.9.3Other descriptive name(R)-troloxamide quinone
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parkinson’s disease
    E.1.1.1Medical condition in easily understood language
    Progressive neurodegenerative disease of the nervous system that affects movement.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061536
    E.1.2Term Parkinson's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effects of the study drug EPI-589 on safety as assessed by occurrence of drug-related serious adverse events in subjects with Parkinson's disease.
    E.2.2Secondary objectives of the trial
    To evaluate the effects of EPI-589 in subjects with Parkinson's disease on:
    1. Fasting glutathione cycle biomarkers as measured in blood, cerebral spinal fluid, and urine
    2. Clinical disease state as assessed by the Movement Disorder Society- sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
    3. Disease morbidity as assessed by the Non-motor Symptoms Scale (NMSS), PDQ-39, and EQ-5D
    4. Cognitive function as assessed by Montreal Cognitive Assessment (MoCA)
    5. Mood as assessed by the Beck Depression Inventory (BDI) and the Montgomery and Asberg Depression rating scale (MADRS)
    6. Pharmacokinetics
    7. Hematology, blood chemistry, electrocardiogram
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hoehn and Yahr stage ≤ 3.0
    2. Ambulatory with or without assistance
    3. 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.
    4. Willingness and ability to comply with study procedures
    5. If on medications for Parkinson's disease drugs, then medication regimen must be stable for 60 days prior to enrollment
    6. Abstention from use of other investigative or non-approved drugs for the duration of the trial
    7. For idiopathic subjects: a diagnosis of idiopathic Parkinson's disease 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
    8. For idiopathic subjects: age 40 to 75 years
    9. For idiopathic subjects: within 5 years of diagnosis of Parkinson’s disease
    10. For genetic subtype subjects: a confirmed diagnosis of Parkinson's disease plus a genetic diagnosis consistent with Parkinson's disease, specifically PINK1, parkin, LARRK2 or other mitochondrial genetic subtype
    11. For genetic subtype subjects: age 21 to 75 years
    E.4Principal exclusion criteria
    1. Allergy to EPI-589 or other components of the EPI-589 tablet formulation
    2. Use of antioxidant supplements, specifically vitamins E and C beyond the recommended daily allowance
    3. Other Parkinsonian disorders
    4. MoCA score of < 24
    5. Revised Hamilton Rating Scale for Depression ≥ 11
    6. Parkinsonism due to drugs or toxins
    7. Diagnosis of any other clinically significant neurologic disease that will confound the assessment of effect of study drug on disease progression
    8. Malignancy within past two years
    9. Pregnant or plans to become pregnant or breast feeding
    10. History of stroke
    11. History of brain surgery
    12. Hepatic insufficiency with liver function tests (LFTs) > 3 times upper limit of normal
    13. Renal insufficiency as defined by creatinine > 1.5 times normal
    14. End stage cardiac failure
    15. Participation within past 3 months and for duration of study in a trial of a device, drug or other therapy for Parkinson's disease
    E.5 End points
    E.5.1Primary end point(s)
    Safety as assessed by occurrence of drug-related serious adverse events in subjects with Parkinson's disease.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Screening (-2 to -1 months), Run-in (-2 to -1 months), Baseline, Month 1, Month 2, Month 3, and Post-Treatment Follow-up (up to 30 days after last dose)
    E.5.2Secondary end point(s)
    EFFICACY
    1. Fasting blood-based biomarkers
    2. Fasting CNS-based biomarkers
    3. Fasting urine-based biomarkers
    4. MDS-UPDRS
    5. NMSS
    6. PDQ-39
    7. EQ-5D
    8. MoCA
    9. BDI
    10. MADRS
    11. Timed motor tests as ON state only (for subjects on dopamine therapy)
    12. Pharmacokinetics

    SAFETY
    13. Routine assessments of AEs and SAEs
    14. Dose limiting toxicities
    15. Routine serum chemistries with liver function tests
    16. C-SSRS
    17. Routine hematology tests with coagulation tests
    18. Electrocardiogram
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Run-in, Baseline, Month 1, and Month 3
    2. Run-in and Month 3
    3. Run-in, Baseline, Month 1, and Month 3
    4. Screening, Baseline, Month 1, and Month 3
    5. Baseline and Month 3
    6. Baseline and Month 3
    7. Baseline and Month 3
    8. Screening and Month 3
    9. Baseline and Month 3
    10. Baseline and Month 3
    11. Run-in, Baseline, and Month 3
    12. Month 1 and Month 3
    13. Screening, Run-in, Baseline, Month 1, Month 2, Month 3, and Post-Treatment Follow-up
    14. Monitored throughout study
    15. Screening, Baseline, Month 1, and Month 3
    16. Baseline, Month 1, and Month 3
    17. Screening, Baseline, Month 1, and Month 3
    18. Screening, Baseline, Month 1, and Month 3
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Within-subject, controlled, open-label study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Natural history of disease
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects who are incapable of giving personal consent may participate in the trial pending their legally authorized representative signs the informed consent form prior to performing any study related procedures.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Since this is a exploratory study, no arrangements are made to continue treatment with EPI-589 after the conclusion of the study period for each subject.

    Patients that have been diagnosed with Parkinson's disease that participated in the study will still have continued care, their condition will be monitored and managed continuously by their Neurologist, and they will also have continued care by their GP.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-08
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