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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
Tablets will be taken orally twice a day
Tablets will be taken orally twice a day.
Tablets will be taken orally twice a day.
Department of Neurology, Shuang Ho Hospital
New Taipei City, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Number of participants experiencing adverse events (AE) and serious adverse events (SAE)
All AEs and SAEs will be assessed following National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Time frame: From Day 1 to Week 76
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score
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 frame: Baseline to Week 72
MDS-UPDRS Part IV score
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.
Time frame: Baseline to Week 72
Sum of MDS-UPDRS Part I score, MDS-UPDRS Part II score and MDS-UPDRS Part III score
* 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.
Time frame: Baseline to Week 72
Proportion of participants with 3-point or more increase in MDS-UPDRS Part III score
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 frame: Baseline to Week 72
Time to onset of motor complication
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.
Time frame: From Day 1 to Week 72
Non-motor symptoms scale (NMSS) total score
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.
Time frame: Baseline to Week 72
Parkinson's Disease Questionnaire-39 (PDQ-39) total score
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.
Time frame: Baseline to Week 72
Modified Hoehn and Yahr stage
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).
Time frame: Baseline to Week 72
Levodopa equivalent daily dose (LEDD) of antiparkinsonian medications
The doses of antiparkinsonian medications will be converted into levodopa equivalent daily dose (LEDD, mg).
Time frame: Baseline to Week 72
Time to the first LEDD adjustment
It refers to the changes in LEDD amount (defined as a ≥10% change in LEDD).
Time frame: From Day 1 to Week 72
Number of participants with abnormalities in vital signs
Vital signs measurement consist of systolic and diastolic blood pressure, respiratory rate, pulse rate, and body temperature.
Time frame: Baseline to Week 76
Number of participants with abnormalities in laboratory examination results
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
Time frame: Baseline to Week 76
Number of participants with toxicity grade change for the laboratory examination results
Toxicity grading will be assessed according to the NCI-CTCAE version 6.0.
Time frame: Baseline to Week 76
Number of participants with abnormalities in physical examination
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.
Time frame: Baseline to Week 76
Number of participants with transition of electrocardiogram results
The results of ventricular rate, PR interval, QRS interval, QT interval, RR interval, and QTcB will be recorded.
Time frame: Baseline to Week 72
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