[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Energenesis Biomedical Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100642015","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-energi-f705-tablets-for-parkinsons-disease-100642015",false,"NCT07647614","A Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets for Parkinson's Disease","A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of ENERGI-F705 Tablets in Combination With Standard of Care for Treating Subjects With Parkinson's Disease","Inclusion Criteria:\n\nA subject is eligible for the study if all of the following apply:\n\n1. With either gender aged ≥ 40 to ≤ 75 years old at Visit 1 (Screening Visit)\n2. 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)\n3. Has a modified Hoehn and Yahr stage of 2 to 3 while assessed in the medication-off state at Visit 1 (Screening Visit)\n4. With MDS-UPDRS Part III (motor examination) score of 15 to 60 while assessed in the medication-off state at Visit 1 (Screening Visit)\n5. 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)\n6. 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:\n\n   * Levodopa\n   * Catechol-O-methyl transferase (COMT) inhibitors\n   * Monoamine Oxidase-B (MAO-B) inhibitors\n   * Ergot-derived dopamine receptor agonists\n   * Non ergot-derived dopamine receptor agonists\n   * Others with established levodopa-conversion factors\n7. Has adequate indices as follows at Visit 1 (Screening Visit):\n\n   * Hematology: white blood cells (WBC) should be ≥ 3,000 cells\u002FμL, platelet count should be ≥ 80,000 per μL of blood\n   * 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)\n   * Liver function: serum total bilirubin should be ≤ 1.5 times ULN, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) should be ≤ 3 times ULN\n   * Renal function: an estimated glomerular filtration rate (eGFR) should be ≥ 60 mL\u002Fmin\u002F1.73m2, calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation\n8. Is willing and able to comply with all required study visits and follow-ups required by this protocol\n9. Understands the study procedures and provided written informed consent (including through use of a legally authorized representative, if necessary)\n10. Is able to complete all subject-reported outcome measures\n\nExclusion Criteria:\n\nAny subject meeting any of the exclusion criteria will be excluded from study participation:\n\n1. Has been diagnosed with atypical Parkinson's disease or secondary parkinsonism\n2. Has any of the following neurosurgical intervention for Parkinson's disease within 2 years prior to or at Visit 2 (Day 1):\n\n   * Deep brain stimulation\n   * Pallidotomy\n   * Thalamotomy\n   * Other procedures that may affect motor function\n3. With Mini-Mental State Examination (MMSE) score of \\\u003C 24 at Visit 1 (Screening Visit)\n4. 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\n5. With history of malignancy or current malignancy within 2 years prior to or at Visit 2 (Day 1)\n6. 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:\n\n   * Cardiovascular (myocardial infarction, congestive heart failure, New York Heart Association Grade III or IV)\n   * Pulmonary (severe chronic obstructive pulmonary disease, pulmonary hypertension, or other clinically significant respiratory conditions)\n   * 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\n7. Administered dopamine-blocking agents within 12 weeks prior to or at Visit 2 (Day 1), including:\n\n   * Typical antipsychotics (e.g., Haloperidol, Chlorpromazine)\n   * Atypical antipsychotics (e.g., Risperidone, Quetiapine or Clozapine)\n8. 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)\n9. 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)\n10. With known hypersensitivity to any component of the investigational product\n11. Has participated in another clinical trial involving an investigational product, medical device, or surgical procedure within 4 weeks prior to Visit 1 (Screening Visit)\n\n    \\* Note: Subjects enrolled in non-interventional clinical trials will be eligible.\n12. Female subject with childbearing potential who is lactating or has positive serum or urine pregnancy test at Visit 2 (Day 1)\n\n    \\* Note: Female subjects with any of following conditions are considered not with childbearing potential\n    * With menopause ≥ 1 year\n    * Prior surgical procedures resulting in infertility\n    * Documented follicle-stimulating hormone or luteinizing hormone levels consistent with postmenopausal status\n13. 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\n\n    \\* Note: At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:\n    * Established use of oral, injected or implanted hormonal methods of contraception\n    * Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n    * Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical\u002Fvault caps)\n14. 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","ALL","40 Years","75 Years",{"count":20,"type":21},105,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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:\n\nDoes ENERGI-F705 Tablets work to treat Parkinson's disease when used with standard-of-care treatment?\n\nInvestigators 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.\n\nParticipants will:\n\n* Take the study drugs twice a day for 72 weeks in the treatment group\n* Take routine use of standard-of-care antiparkinsonian medications throughout the study\n* Visit the outpatient department at scheduled visits, ranging from Day 1 to approximately every 1 to 4 weeks thereafter, for checkups and tests",[27],"Parkinson's Disease (PD)",[29,30,31,32,33],"Phase II","Randomized","Double blind","ENERGI","Parkinson' disease","NOT_YET_RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":21},"2026-12-01",{"date":42,"type":21},"2030-01-01",{"name":44,"class":45},"Energenesis Biomedical Co., Ltd.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100510728","phase-3-a-study-to-evaluate-energi-f703-gel-in-diabetic-foot-ulcer-100510728","NCT05930210","A Study to Evaluate ENERGI-F703 GEL in Diabetic Foot Ulcer","A Randomized, Double-Blind, Vehicle-controlled, Parallel, Phase III Study to Evaluate Efficacy and Safety of ENERGI-F703 GEL in Subjects With Diabetic Foot Ulcers","Inclusion Criteria:\n\n1. Subject must be at least 18 years old.\n2. Subject must have diagnosed with diabetes mellitus (DM), eg, currently under DM medication treatment or subjects with naïve DM with duplicated hemoglobin A1c over 6.5% and fasting plasma glucose over 126 mg\u002FdL measured at least 1 week apart before screening.\n3. Subject must have at least 1 cutaneous ulcer on the foot and not healing for at least 4 weeks. The largest diabetic foot ulcer will be selected as target ulcer. If 2 or more ulcers have the largest size, the one with worst grade will be selected. If 2 or more ulcers have the largest size and grade, the one with longest duration will be selected.\n4. The target ulcer is classified as Grade 1 to Grade 2 ulcer according to Wagner Grading System and with ulcer size of 1.5 cm2 to 25 cm2.\n5. Diabetic foot ulcers should be free of any necrosis or infection\n6. Subject has signed the written informed consent form\n7. Male subjects must be surgically sterile or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence for the duration of the study and for 30 days after study treatment administration.\n8. Female subjects are eligible only if all of the following apply:\n\n   * Not pregnant with a negative serum pregnancy test at Screening visit and negative urine pregnancy test within 24 hours before randomization (test not required for females of non-childbearing potential, defined as surgically sterile \\[eg, hysterectomy or bilateral oophorectomy\\] or postmenopausal \\[amenorrheic for at least 1 year\\])\n   * Not lactating\n   * Not planning to become pregnant during the study\n   * If of childbearing potential, commits to the use of a highly effective method of contraception for the duration of the study and at least 30 days after study treatment administration.\n\nExclusion Criteria:\n\n1. History or evidence of osteomyelitis as confirmed by the investigator. An x-ray\u002Fpathology assessment of debridement or a probe-to-bone (PTB) test will be used to determine presence of osteomyelitis. However, participants who have a history or evidence of osteomyelitis in other parts of their body are eligible to participate in the study. If the medical history of osteomyelitis was cured by antibiotic therapy, surgery or amputation for more than 1 year, and no recurrence, no finding to the current leg and foot after testing, the participant can be enrolled\n2. With target ulcer size decreased by at least 30% after at least 2 weeks of standard of care-only period between screening and randomization\n3. Subjects with highly exudated wounds which require dressing changes more than 3 times a day may be enrolled, but heavily exudated wounds should not be selected as target ulcers\n4. With poor nutritional status (serum albumin \\\u003C2g\u002FdL or prealbumin \\\u003C10 mg\u002FdL), poor diabetic control (hemoglobin A1c \\>12%), a leukocyte counts \\\u003C2,000\u002Fmm3, abnormal liver function (aspartate aminotransferase, alanine aminotransferase \\>3 x upper limit of normal range) within 21 days before Randomization visit\n5. Requiring treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents\n6. With known or suspected hypersensitivity to any ingredients of study product and vehicle\n7. With coronary heart disease with myocardial infarction, coronary artery bypass graft, or percutaneous transluminal coronary angioplasty within 3 months prior to study (patients who have undergone peripheral angioplasty should be excluded unless the surgery was performed at least 30 days prior to screening)\n8. Known or suspected history of drug abuse or a recent history of alcohol abuse (regularly drinks \\>4 units of alcohol per day: 1 unit = 8 oz. beer, 3 oz. wine, or 1 oz. spirits) within 6 months prior to screening (within 6 months prior to screening includes both drug abuse and alcohol abuse)\n9. History or positive test results for HIV\n10. Malignancy in the last 2 years, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix\n11. Ankle brachial index \\\u003C0.8 or \\>1.4\n12. Enrollment in any investigational drug trial within 4 weeks before entering this study\n13. With any condition judged by the investigator that entering the trial may be detrimental to the subject -","18 Years",{"count":55,"type":21},230,[57],"PHASE3","This Phase 3 study is a randomized, double-blind, vehicle-controlled, multiple-center, parallel study to evaluate efficacy and safety of ENERGI-F703 GEL compared with vehicle control in subjects with Wagner Grade 1 to Grade 2 diabetic foot ulcers. Baseline target ulcer size (\\\u003C16 cm2 vs ≥16 cm2 ) will be included as a stratification factor. Subjects will be randomized 1:1 to receive ENERGI-F703 GEL or vehicle control using an interactive web response system for randomization to automatically assign a unique subject randomization number. Total duration of the study will be up to 31 weeks including Screening visit (approximately 2 to 3 weeks), double-blind dosing\u002Fobservation phase (16 weeks), and a safety follow-up of 12 weeks after the last administration of study treatment.",[60,61,62,63],"Diabetic Foot Ulcer","Foot Ulcer","Diabetes Mellitus","Wound",[60,62,65],"Wound Healing","RECRUITING","2025-09-29",{"date":69,"type":38},"2025-10-02",{"date":71,"type":38},"2023-05-30",{"date":73,"type":21},"2026-03-31",{"name":44,"class":45},24,""]