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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-75
SponsorEnergenesis Biomedical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Deep brain stimulation

Pallidotomy

Thalamotomy

Trial design

Treatments tested in this trial

  • 60 milligrams of ENERGI-F705 Tablets
  • Placebo tablets
  • 120 milligrams of ENERGI-F705 Tablets

Treatment groups

105 Participants
are divided into 3 treatment groups