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

Phase 1

• Conditions: Parkinson’s disease; MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-001786-10-GB
• Lead Sponsor: BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-23
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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 and supplements for Parkinson's disease, then 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, LRRK2 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. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified