A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets in Combination With Standard of Care for Treating Subjects With Parkinson's Disease
A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets in Combination With Standard of Care for Treating Subjects With Parkinson's Disease
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:
Inclusion Criteria:
A subject is eligible for the study if all of the following apply:
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)
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)
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:
Has adequate indices as follows at Visit 1 (Screening Visit):
Is willing and able to comply with all required study visits and follow-ups required by this protocol
Understands the study procedures and provided written informed consent (including through use of a legally authorized representative, if necessary)
Is able to complete all subject-reported outcome measures
Exclusion Criteria:
Any subject meeting any of the exclusion criteria will be excluded from study participation:
Has been diagnosed with atypical Parkinson's disease or secondary parkinsonism
Has any of the following neurosurgical intervention for Parkinson's disease within 2 years prior to or at Visit 2 (Day 1):
With Mini-Mental State Examination (MMSE) score of < 24 at Visit 1 (Screening Visit)
With a lifetime history of significant psychiatric disorder (e.g., alcohol use disorder, drug abuse, or suicide attempt), which in the investigator's opinion, may interfere with study participation
With history of malignancy or current malignancy within 2 years prior to or at Visit 2 (Day 1)
With ongoing or a documented history of within 2 years prior to or at Visit 2 (Day 1) of acute diseases or severe medical conditions, including:
Administered dopamine-blocking agents within 12 weeks prior to or at Visit 2 (Day 1), including:
With clinically significant gastrointestinal disorders that may affect oral drug absorption or tolerability (e.g., inflammatory bowel disease within 12 weeks prior to or at Visit 2 (Day 1) or relevant gastrointestinal surgery recorded on a lifetime basis)
With a history of gout or urolithiasis, or treatment with medications for gout or urolithiasis, within 2 years prior to or at Visit 2 (Day 1)
With known hypersensitivity to any component of the investigational product
Has participated in another clinical trial involving an investigational product, medical device, or surgical procedure within 4 weeks prior to Visit 1 (Screening Visit)
* Note: Subjects enrolled in non-interventional clinical trials will be eligible.
Female subject with childbearing potential who is lactating or has positive serum or urine pregnancy test at Visit 2 (Day 1)
* Note: Female subjects with any of following conditions are considered not with childbearing potential
Female subjects with childbearing potential or male subjects with partners of childbearing potential who refuse to use highly effective contraceptives from signing informed consent until the end of study (EOS) or early termination (ET) visit
* Note: At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
Is an employee of the investigator's site, the sponsor, or its delegate (e.g., contract research organization) who is directly involved in the conduct of the study
ct@energenesis-biomedical.com+886-2-26270835
ct@energenesis-biomedical.com+886-2-26270835