Parkinson's Disease (PD)
Conditions
Keywords
Phase II, Randomized, Double blind, ENERGI, Parkinson' disease
Brief summary
The goal of this clinical trial is to learn if this study drug, ENERGI-F705 Tablets, is safe and works to treat participants who have Parkinson's disease and are currently on standard-of-care antiparkinsonian medications. The main question it aims to answer is: Does ENERGI-F705 Tablets work to treat Parkinson's disease when used with standard-of-care treatment? Investigators will compare the three treatment groups, high-dose ENERGI-F705 Tablets (120 milligrams twice daily), low-dose ENERGI-F705 Tablets (60 milligrams twice daily), and placebo tablets (a look-alike substance that contains no drug), to see if ENERGI-F705 Tablets work to treat Parkinson's disease. Participants will: * Take the study drugs twice a day for 72 weeks in the treatment group * Take routine use of standard-of-care antiparkinsonian medications throughout the study * Visit the outpatient department at scheduled visits, ranging from Day 1 to approximately every 1 to 4 weeks thereafter, for checkups and tests
Interventions
DRUG60 milligrams of ENERGI-F705 Tablets
Tablets will be taken orally twice a day
DRUGPlacebo tablets
Tablets will be taken orally twice a day.
DRUG120 milligrams of ENERGI-F705 Tablets
Tablets will be taken orally twice a day.
Sponsors
Energenesis Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
A subject is eligible for the study if all of the following apply: 1. With either gender aged ≥ 40 to ≤ 75 years old at Visit 1 (Screening Visit) 2. Has been diagnosed with idiopathic Parkinson's disease (defined by the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's disease) for ≥ 2 years prior to or at Visit 2 (Day 1) 3. Has a modified Hoehn and Yahr stage of 2 to 3 while assessed in the medication-off state at Visit 1 (Screening Visit) 4. With MDS-UPDRS Part III (motor examination) score of 15 to 60 while assessed in the medication-off state at Visit 1 (Screening Visit) 5. Without motor complications, which is defined as a score of 2 or less on the MDS-UPDRS Part IV score at Visit 1 (Screening Visit) 6. Has received a stable standard-of-care regimen, as determined by the investigator, during the 12 weeks prior to Visit 2 (Day 1) and is currently on the following antiparkinsonian medications with an average levodopa equivalent daily dose (LEDD) of ≥ 300 mg during the same period, including: * Levodopa * Catechol-O-methyl transferase (COMT) inhibitors * Monoamine Oxidase-B (MAO-B) inhibitors * Ergot-derived dopamine receptor agonists * Non ergot-derived dopamine receptor agonists * Others with established levodopa-conversion factors 7. Has adequate indices as follows at Visit 1 (Screening Visit): * Hematology: white blood cells (WBC) should be ≥ 3,000 cells/μL, platelet count should be ≥ 80,000 per μL of blood * Coagulation: prothrombin time, international normalized ratio (INR), and activated partial thromboplastin time (APTT), all of which should be ≤ 1.5 times the upper limit of the normal range (ULN) * Liver function: serum total bilirubin should be ≤ 1.5 times ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be ≤ 3 times ULN * Renal function: an estimated glomerular filtration rate (eGFR) should be ≥ 60 mL/min/1.73m2, calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 8. Is willing and able to comply with all required study visits and follow-ups required by this protocol 9. Understands the study procedures and provided written informed consent (including through use of a legally authorized representative, if necessary) 10. Is able to complete all subject-reported outcome measures
Exclusion criteria
Any subject meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants experiencing adverse events (AE) and serious adverse events (SAE) | From Day 1 to Week 76 | All AEs and SAEs will be assessed following National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score | Baseline to Week 72 | MDS-UPDRS Part III is a scale used by the investigator to evaluate motor functions of Parkinson's disease. The total score ranges from 0 to 132. The higher score indicates more difficulties with movements. |
| MDS-UPDRS Part IV score | Baseline to Week 72 | MDS-UPDRS Part IV is a scale used by the investigator to evaluate the motor complications in Parkinson's disease. The total score ranges from 0 to 24 with the higher score indicating greater impact on the daily life due to motor complications. |
| Sum of MDS-UPDRS Part I score, MDS-UPDRS Part II score and MDS-UPDRS Part III score | Baseline to Week 72 | * MDS-UPDRS Part I is a scale, consisting of Part IA (conducted by healthcare professionals) and Part IB (participant's self-assessment), to assess how non-motor symptoms impact daily living. The total score ranges from 0 to 52. The higher score indicates more non-motor symptoms or greater impact on the activities of daily living due to non-motor symptoms. * MDS-UPDRS Part II is a participant's self-assessment to observe how motor symptoms affect your daily living. The total score ranges from 0 to 52. The higher score indicates more motor symptoms or greater impact on the activities of daily living. * MDS-UPDRS Part III is a scale used by the investigator to evaluate motor functions of Parkinson's disease. The total score ranges from 0 to 132. The higher score indicates more difficulties with movements. |
| Proportion of participants with 3-point or more increase in MDS-UPDRS Part III score | Baseline to Week 72 | MDS-UPDRS Part III is a scale used by the investigator to evaluate motor functions of Parkinson's disease. The total score ranges from 0 to 132. The higher score indicates more difficulties with movements. |
| Time to onset of motor complication | From Day 1 to Week 72 | The motor complication events are collected from the MDS-UPDRS Part IV, a scale to evaluate the motor complication in Parkinson's disease. The total score ranges from 0 to 24 with the higher score indicating greater impact on the daily life due to motor complications. |
| Non-motor symptoms scale (NMSS) total score | Baseline to Week 72 | NMSS is a scale to assess non-motor symptoms in Parkinson's disease. It contains 9 subdomains and the total score ranges from 0 to 360. The higher score indicates greater burden of non-motor symptoms. |
| Parkinson's Disease Questionnaire-39 (PDQ-39) total score | Baseline to Week 72 | PDQ-39 score is to assess the health-related quality of life with Parkinson's disease. The total score is transformed into a percentage score between 0 to 100 with higher percentage indicating worsen health-related quality of life due to Parkinson's disease. |
| Modified Hoehn and Yahr stage | Baseline to Week 72 | Modified Hoehn and Yahr stage is a scale to evaluate severity of Parkinson's disease in 8 stages. The staging ranges from Stage 0 (No sings of disease) to Stage 5 (Wheelchair bound or bedridden unless aided). |
| Levodopa equivalent daily dose (LEDD) of antiparkinsonian medications | Baseline to Week 72 | The doses of antiparkinsonian medications will be converted into levodopa equivalent daily dose (LEDD, mg). |
| Time to the first LEDD adjustment | From Day 1 to Week 72 | It refers to the changes in LEDD amount (defined as a ≥10% change in LEDD). |
| Number of participants with abnormalities in vital signs | Baseline to Week 76 | Vital signs measurement consist of systolic and diastolic blood pressure, respiratory rate, pulse rate, and body temperature. |
| Number of participants with abnormalities in laboratory examination results | Baseline to Week 76 | Laboratory examinations consist of the followings: * Hematology: hemoglobin, hematocrit, red blood cell (RBC), platelet, white blood cell (WBC) with differential counts, prothrombin time, international normalized ratio (INR), and activated partial thromboplastin time (APTT) * Biochemistry: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), uric acid, blood urea nitrogen (BUN), serum albumin, creatinine, and estimated glomerular filtration rate (eGFR) * Urinalysis: color, appearance, specific gravity, pH, protein, glucose, occult blood, ketones, leukocyte esterase, nitrite, bilirubin, urobilinogen, and microscopic examination of urine sediment |
| Number of participants with toxicity grade change for the laboratory examination results | Baseline to Week 76 | Toxicity grading will be assessed according to the NCI-CTCAE version 6.0. |
| Number of participants with abnormalities in physical examination | Baseline to Week 76 | Physical examinations include general appearance, skin, eyes, ears, nose, throat, head and neck (including thyroid), heart, chest and lungs, abdomen, extremities, lymph nodes, musculoskeletal, neurological system, and other body systems if applicable for describing the status of the subject's health. |
| Number of participants with transition of electrocardiogram results | Baseline to Week 72 | The results of ventricular rate, PR interval, QRS interval, QT interval, RR interval, and QTcB will be recorded. |
Countries
Taiwan
Contacts
CONTACTYifang Cheng, PhD
PRINCIPAL_INVESTIGATORTu-Hsueh YEH, M.D.
Department of Neurology, Taipei Medical University Hospital
PRINCIPAL_INVESTIGATORChien-Tai Hong, M.D.
Department of Neurology, Shuang Ho Hospital
Outcome results
None listed