KCT0004536
Not yet recruiting
未知
A clinical study to determine the optimal dose of WIN-1001X by evaluating its efficacy and safety in patients with early Parkinson’s disease: double-blind, randomized, placebo-controlled, multicenter, phase II study
Medihelpline0 sites188 target enrollmentTBD
ConditionsDiseases of the nervous system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the nervous system
- Sponsor
- Medihelpline
- Enrollment
- 188
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Subjects \=30 years old at the time of informed consent
- •2\) Subjects diagnosed with Parkinson’s disease satisfying the UKPDSBB (United Kingdom Parkinson’s Disease Society Brain Bank) Clinical Diagnostic Criteria and showing decreased dopamine transporters in the dopamine transporter imaging (e.g.: ¹8F\-FP\-CIT PET, etc.)
- •3\) Modified Hoehn and Yahr stage \= 3\.0
- •4\) K\-MMSE (Korean Mini\-Mental State Examination) score \=20 at the screening visit (visit 1\)
- •5\) Subjects who can understand and follow the instructions on this clinical study, and fully participate in the clinical study
- •6\) MDS UPDRS Part ?\+Part ? score \=18 at baseline (visit 2\)
- •7\) Subjects who have voluntarily determined to participate in this study and signed the written informed consent form
Exclusion Criteria
- •1\) Atypical or secondary parkinsonism or benign tremulous parkinsonism
- •2\) History of treatments with levodopa, dopamine agonists, anticholinergics, MAO\-B inhibitors, COMT inhibitors,
- •amantadine, or NMDA receptor antagonists (However, subjects who have not been administered such drugs for at least 6 months in a row and have no history of treatment within 4 weeks prior to their written consent can be enrolled)
- •3\) In case the investigators determine the symptom control is difficult with placebo
- •4\) Hypersensitivity to herbal medicine
- •5\) Subjects with dementia whose K\-MMSE score is \=19, severe psychopathy requiring treatment or hallucination
- •6\) Any disorder that may affect the absorption, distribution, metabolism, and excretion of drugs
- •7\) Clinically significant heart disease
- •8\) Clinically significant hepatic insufficiency (in case of total bilirubin \>2\.0 mg/dL, or ALT and/or AST \>2 times of upper limit of normal)
- •9\) Clinically significant renal insufficiency (serum
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
Dose finding study for deciding the optimal dose of fluorescein during probe based confocal endomicroscopyJPRN-UMIN000027696ational Cancer Center Hospital24
Completed
Phase 1
Dose-escalation safety of novel fungal beta-glucanshealthy adult individualsbeta-GlucansPolysaccharidesOligosaccharidesFungiClinical TrialSafetyDietary SupplementsDose-escalation studyTCTR20240705004Institute of Nutrition, Mahidol University18
Completed
Not Applicable
Clinical dose-finding study to assess the effect of ABAlifeTM on postprandial blood glucose profile in prediabetic subjects: randomized, multicentric, double-blind, placebo-controlled, cross-over study with different dosages combined with a 12-weeks follow-up phasePre-DiabetesDRKS00026093Anton Hübner GmbH & Co. KG61
Active, not recruiting
Phase 1
Phase II Clinical Trial to optimize the dose of an anti-NKG2A monoclonal antibody (humZ270 mAb, IPH2201) for patients with acute myeloid leukemia or myelodysplastic syndrome undergoing haploidentical transplantation with posttransplantation cyclophosphamide.Patients with acute myeloid leukemia or myelodysplastic syndrome undergoing haploidentical transplantation with posttransplantation cyclophosphamide.MedDRA version: 21.1Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2020-005902-24-ITIRCCS ISTITUTO CLINICO HUMANITAS42
Active, not recruiting
Not Applicable
Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 yearsEUCTR2011-001292-39-HUInstitut de Recherches Internationales Servier90