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

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Interventions: ENERGI-F705 Tablets (Drug), Placebo tablets (Drug) to 120 milligrams of ENERGI-F705 Tablets (Drug), 60 milligrams of ENERGI-F705 Tablets (Drug), Placebo tablets (Drug)
    • Secondary endpoints: details revised at 1 of 15 entries
    • Study title shortened, about 2 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07647614
Lead Sponsor Energenesis Biomedical Co., Ltd.
Conditions
(from sponsor)		 Parkinson's Disease (PD)
Related terms Parkinson Disease
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov