drugset / Trial / NCT07647614

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

NCT07647614 ↗

Phase 2 Not yet recruiting 105 enrolled Energenesis Biomedical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2026-12-01
Primary completion
2030-01-01
Completion
2030-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject ENERGI-F705 Unknown 60 mg Oral
Subject ENERGI-F705 Unknown 120 mg Oral

Indications