A Phase II Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets for Parkinson's Disease (NCT07647614) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets for Parkinson's Disease
Taiwan105 participantsStarted 2026-12-01
Plain-language 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
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is still in Phase II and hasn't started recruiting yet, what does that mean for how much is already known about the safety of ENERGI-F705 tablets in people with Parkinson's disease?
2The main thing this trial is measuring is how many participants experience side effects or serious adverse events — does that suggest the researchers are still primarily focused on safety rather than proving the drug works, and how should that affect my decision about whether to consider it?
3Given that this trial hasn't started recruiting yet, how long might it realistically be before it opens and I could even be considered for participation — and is waiting a good option given where I am in my Parkinson's progression?
4Are there currently approved or standard treatments for my stage of Parkinson's disease that I should try first, before considering an experimental tablet like ENERGI-F705 that is still in early human testing?
5If this trial does open and I were to discuss enrolling, what kinds of serious adverse events have typically been a concern in early-phase Parkinson's drug trials, so I understand what the safety monitoring in this study is designed to watch for?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants experiencing adverse events (AE) and serious adverse events (SAE)
. Has adequate indices as follows at Visit 1 (Screening Visit):
. Is willing and able to comply with all required study visits and follow-ups required by this protocol
Exclusion criteria
. 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):
. 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:
. Administered dopamine-blocking agents within 12 weeks prior to or at Visit 2 (Day 1), including:
. With clinically significant gastrointestinal disorders that may affect oral drug absorption or tolerability (e.g., inflammatory bowel disease within 12 weeks prior to or at Visit 2 (Day 1) or relevant gastrointestinal surgery recorded on a lifetime basis)