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

NCT07647614 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-07-02

No results posted yet for this study

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)

Interventions

DRUG

60 milligrams of ENERGI-F705 Tablets

Tablets will be taken orally twice a day

DRUG

Placebo tablets

Tablets will be taken orally twice a day.

DRUG

120 milligrams of ENERGI-F705 Tablets

Tablets will be taken orally twice a day.

Sponsors & Collaborators

  • Energenesis Biomedical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tu-Hsueh YEH, M.D. · Department of Neurology, Taipei Medical University Hospital

  • Chien-Tai Hong, M.D. · Department of Neurology, Shuang Ho Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2030-01-01
Completion
2030-01-01
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647614 on ClinicalTrials.gov