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New pill aims to ease Parkinson's motor symptoms when added to standard therapy

NCT ID NCT07647614

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether ENERGI-F705 tablets, taken twice daily alongside standard Parkinson's medications, can improve motor function and safety in people aged 40–75 with idiopathic Parkinson's disease. Participants are randomly assigned to receive a high dose, low dose, or placebo for 72 weeks. The study measures side effects and changes in movement using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ENERGI-F705 tablets
What this could lead to
If successful, this could provide a new add-on treatment option to help control motor symptoms in people with Parkinson's disease.
What could go wrong
This is an early phase 2 trial with only 105 participants, so results may not apply to everyone. The drug may cause side effects or fail to show benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 105 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: A subject is eligible for the study if all of the following apply: 1. With either gender aged ≥ 40 to ≤ 75 years old at Visit 1 (Screening Visit) 2. 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) 3. Has a modified Hoehn and Yahr stage of 2 to 3 while assessed in the medication-off state at Visit 1 (Screening Visit) 4. With MDS-UPDRS Part III (motor examination) score of 15 to 60 while assessed in the medication-off state at Visit 1 (Screening Visit) 5. 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) 6. 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: * Levodopa * Catechol-O-methyl transferase (COMT) inhibitors * Monoamine Oxidase-B (MAO-B) inhibitors * Ergot-derived dopamine receptor agonists * Non ergot-derived dopamine receptor agonists * Others with established levodopa-conversion factors 7. Has adequate indices as follows at Visit 1 (Screening Visit): * Hematology: white blood cells (WBC) should be ≥ 3,000 cells/μL, platelet count should be ≥ 80,000 per μL of blood * Coagulation: prothrombin time, international normalized ratio (INR), and activated partial thromboplastin time (APTT), all of which should be ≤ 1.5 times the upper limit of the normal range (ULN) * Liver function: serum total bilirubin should be ≤ 1.5 times ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be ≤ 3 times ULN * Renal function: an estimated glomerular filtration rate (eGFR) should be ≥ 60 mL/min/1.73m2, calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 8. Is willing and able to comply with all required study visits and follow-ups required by this protocol 9. Understands the study procedures and provided written informed consent (including through use of a legally authorized representative, if necessary) 10. Is able to complete all subject-reported outcome measures Exclusion Criteria: Any subject meeting any of the exclusion criteria will be excluded from study participation: 1. Has been diagnosed with atypical Parkinson's disease or secondary parkinsonism 2. Has any of the following neurosurgical intervention for Parkinson's disease within 2 years prior to or at Visit 2 (Day 1): * Deep brain stimulation * Pallidotomy * Thalamotomy * Other procedures that may affect motor function 3. With Mini-Mental State Examination (MMSE) score of \< 24 at Visit 1 (Screening Visit) 4. 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 5. With history of malignancy or current malignancy within 2 years prior to or at Visit 2 (Day 1) 6. 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: * Cardiovascular (myocardial infarction, congestive heart failure, New York Heart Association Grade III or IV) * Pulmonary (severe chronic obstructive pulmonary disease, pulmonary hypertension, or other clinically significant respiratory conditions) * Current severe infections, medical history, physical examination findings, or laboratory examination abnormality that in the investigators' opinion are not in stable condition and participating in the study could interfere with the results of the trial or adversely affect the safety of the subject 7. Administered dopamine-blocking agents within 12 weeks prior to or at Visit 2 (Day 1), including: * Typical antipsychotics (e.g., Haloperidol, Chlorpromazine) * Atypical antipsychotics (e.g., Risperidone, Quetiapine or Clozapine) 8. 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) 9. With a history of gout or urolithiasis, or treatment with medications for gout or urolithiasis, within 2 years prior to or at Visit 2 (Day 1) 10. With known hypersensitivity to any component of the investigational product 11. Has participated in another clinical trial involving an investigational product, medical device, or surgical procedure within 4 weeks prior to Visit 1 (Screening Visit) \* Note: Subjects enrolled in non-interventional clinical trials will be eligible. 12. Female subject with childbearing potential who is lactating or has positive serum or urine pregnancy test at Visit 2 (Day 1) \* Note: Female subjects with any of following conditions are considered not with childbearing potential * With menopause ≥ 1 year * Prior surgical procedures resulting in infertility * Documented follicle-stimulating hormone or luteinizing hormone levels consistent with postmenopausal status 13. Female subjects with childbearing potential or male subjects with partners of childbearing potential who refuse to use highly effective contraceptives from signing informed consent until the end of study (EOS) or early termination (ET) visit \* Note: At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include: * Established use of oral, injected or implanted hormonal methods of contraception * Placement of an intrauterine device (IUD) or intrauterine system (IUS) * Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical/vault caps) 14. Is an employee of the investigator's site, the sponsor, or its delegate (e.g., contract research organization) who is directly involved in the conduct of the study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Neurology, Shuang Ho Hospital

    New Taipei City, Taiwan

  • Taipei Medical University Hospital

    Taipei, Taiwan

More trials for these conditions

Other studies related to the condition(s) this trial covers.