A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease.

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2015-001786-10-DE
• Date of registration: 07/04/2016
• Prospective Registration: Yes
• Primary sponsor: BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)
• Public title: A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease.
• Scientific title: A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease
• Date of first enrolment: 24/10/2016
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001786-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Within-subject, controlled, open-label study; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Natural history of disease; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany, United Kingdom, United States

Contacts

• Name: BioElectron info e-mail address
• Affiliation: BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)

• Name: BioElectron info e-mail address
• Affiliation: BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)

Key inclusion & exclusion criteria

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Parkinson’s disease
MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: EPI-589
Product Code: EPI-589
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Kinoquinone (proposed)
CAS Number: 1147883-03-1
Current Sponsor code: EPI-589
Other descriptive name: (R)-troloxamide quinone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-

Primary Outcome(s)

Primary end point(s): Safety as assessed by occurrence of drug-related serious adverse events in subjects with Parkinson's disease.

Timepoint(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)

Secondary Objective: 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

Main Objective: 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.

Secondary Outcome(s)

Secondary 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

Timepoint(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

Secondary ID(s)

EPI589-15-002

NCT02462603

2015-001786-10-GB

Source(s) of Monetary Support

BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)

Ethics review

Status: Approved
Approval date:
Contact: