A Phase II Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets for 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:

• 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 Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease (PD)
• Intervention / Treatment: Drug: ENERGI-F705 Tablets; Drug: Placebo tablets

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yifang Cheng, PhD; Phone Number: +886-2-26270835; Email: ct@energenesis-biomedical.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Department of Neurology, Shuang Ho Hospital
    • Contact: Yifang Cheng, Ph.D.; Phone Number: +886-2-26270835; Email: ct@energenesis-biomedical.com
  • Taipei, Taiwan
    • Taipei Medical University Hospital
    • Contact: Yifang Cheng, PhD; Phone Number: +886-2-26270835; Email: ct@energenesis-biomedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 exclusion criteria will be excluded from study participation:

1. Has been diagnosed with atypical Parkinson's disease or secondary parkinsonism

2. Has any of the following neurosurgical intervention for Parkinson's disease within 2 years prior to or at Visit 2 (Day 1):

   • Deep brain stimulation
   • Pallidotomy
   • Thalamotomy
   • Other procedures that may affect motor function
3. With Mini-Mental State Examination (MMSE) score of < 24 at Visit 1 (Screening Visit)
4. 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
5. With history of malignancy or current malignancy within 2 years prior to or at Visit 2 (Day 1)

6. 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:

   • Cardiovascular (myocardial infarction, congestive heart failure, New York Heart Association Grade III or IV)
   • Pulmonary (severe chronic obstructive pulmonary disease, pulmonary hypertension, or other clinically significant respiratory conditions)
   • Current severe infections, medical history, physical examination findings, or laboratory examination abnormality that in the investigators' opinion are not in stable condition and participating in the study could interfere with the results of the trial or adversely affect the safety of the subject

7. Administered dopamine-blocking agents within 12 weeks prior to or at Visit 2 (Day 1), including:

   • Typical antipsychotics (e.g., Haloperidol, Chlorpromazine)
   • Atypical antipsychotics (e.g., Risperidone, Quetiapine or Clozapine)
8. 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)
9. 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)
10. With known hypersensitivity to any component of the investigational product

11. 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.

12. 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

    • With menopause ≥ 1 year
    • Prior surgical procedures resulting in infertility
    • Documented follicle-stimulating hormone or luteinizing hormone levels consistent with postmenopausal status

13. 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:

    • Established use of oral, injected or implanted hormonal methods of contraception
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS)
    • Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps)
14. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose ENERGI-F705 Tablets; 60 milligrams of ENERGI-F705 Tablets will be taken orally twice a day	Drug: ENERGI-F705 Tablets; Oral tablets with active pharmaceutical ingredient
Experimental: High-dose ENERGI-F705 Tablets; 120 milligrams of ENERGI-F705 Tablets will be taken orally twice a day	Drug: ENERGI-F705 Tablets; Oral tablets with active pharmaceutical ingredient
Placebo Comparator: Placebo tablets; Placebo tables will be taken orally twice a day	Drug: Placebo tablets; Oral tablets contains the same excipients as ENERGI-F705 Tablets except for the active pharmaceutical ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Day 1 to Week 76

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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).	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).	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).	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.	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	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.	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.	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.	Baseline to Week 72

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenosine triphosphate (ATP) levels in whole blood samples	The ATP level will be measured using a qualified analytical method at a contracted central laboratory.	Baseline to Week 76

Collaborators and Investigators

• Sponsor: Energenesis Biomedical Co., Ltd.
• Investigators: Principal Investigator: Tu-Hsueh YEH, M.D., Department of Neurology, Taipei Medical University Hospital; Principal Investigator: Chien-Tai Hong, M.D., Department of Neurology, Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Randomized; Phase II; Double blind; Parkinson' disease; ENERGI
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: ENERGI-F705-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No