A Phase II Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets for Parkinson's Disease

NCT07647614 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ENERGI-F705-02
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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

Conditions

Parkinson's Disease (PD)

Keywords

Phase II; Randomized; Double blind; ENERGI; Parkinson' disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score

  Baseline to Week 72

• MDS-UPDRS Part IV score

  Baseline to Week 72

• Sum of MDS-UPDRS Part I score, MDS-UPDRS Part II score and MDS-UPDRS Part III score

  Baseline to Week 72

• Proportion of participants with 3-point or more increase in MDS-UPDRS Part III score

  Baseline to Week 72

• Time to onset of motor complication

  From Day 1 to Week 72

Other Outcomes (1)

• Adenosine triphosphate (ATP) levels in whole blood samples

  Baseline to Week 76

Study Arms (3)

Low-dose ENERGI-F705 Tablets

EXPERIMENTAL

60 milligrams of ENERGI-F705 Tablets will be taken orally twice a day

Drug: ENERGI-F705 Tablets

High-dose ENERGI-F705 Tablets

EXPERIMENTAL

120 milligrams of ENERGI-F705 Tablets will be taken orally twice a day

Drug: ENERGI-F705 Tablets

Placebo tablets

PLACEBO COMPARATOR

Placebo tables will be taken orally twice a day

Drug: Placebo tablets

Interventions

ENERGI-F705 Tablets DRUG

Oral tablets with active pharmaceutical ingredient

High-dose ENERGI-F705 Tablets; Low-dose ENERGI-F705 Tablets

Placebo tablets DRUG

Oral tablets contains the same excipients as ENERGI-F705 Tablets except for the active pharmaceutical ingredient

Placebo tablets

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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

You may not qualify if:

• 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):
• Deep brain stimulation
• Pallidotomy
• Thalamotomy
• Other procedures that may affect motor function
• 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:
• 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
• Administered dopamine-blocking agents within 12 weeks prior to or at Visit 2 (Day 1), including:
• Typical antipsychotics (e.g., Haloperidol, Chlorpromazine)

Sponsors & Collaborators

• Energenesis Biomedical Co., Ltd.: lead

Study Sites (2)

Department of Neurology, Shuang Ho Hospital

New Taipei City, Taiwan

Location

Taipei Medical University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifang Cheng, PhD

CONTACT

+886-2-26270835; ct@energenesis-biomedical.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

TW (2)