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
With either gender aged ≥ 40 to ≤ 75 years old at Visit 1 (Screening Visit)
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)
Has a modified Hoehn and Yahr stage of 2 to 3 while assessed in the medication-off state at Visit 1 (Screening Visit)
With MDS-UPDRS Part III (motor examination) score of 15 to 60 while assessed in the medication-off state at Visit 1 (Screening Visit)
Has been diagnosed with atypical Parkinson's disease or secondary parkinsonism
Deep brain stimulation
Pallidotomy
Thalamotomy
Parallel
60 milligrams of ENERGI-F705 Tablets
DrugTablets will be taken orally twice a day
Placebo tablets
DrugTablets will be taken orally twice a day.
120 milligrams of ENERGI-F705 Tablets
DrugTablets will be taken orally twice a day.
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.
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.
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.
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.
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.
Adenosine triphosphate (ATP) levels in whole blood samples
The ATP level will be measured using a qualified analytical method at a contracted central laboratory.
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