NL-OMON49757招募中不适用
Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson*s Disease patients. - Validation of finger tapping in PD patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Aged 20-69 years, inclusive at screening.
- •2. Clinical diagnosis (confirmed by a neurologist) of PD and classified by the
- •investigator as Hoehn & Yahr stage I-III in the ON state.
- •3. Subject has self-described motor fluctuations and recognizable OFF periods.
- •4. Taking oral anti-Parkinson medication and willing to withhold medication
- •overnight for study purposes.
- •5. Known to be levodopa responsive, either by current use or historical use of
- •6. Willing and able to maintain stable doses and regimens for all medications,
- •herbal treatments and dietary supplements from the screening visit through the
- •last study visit.
- •7. Negative urine tests for selected drugs of abuse. However, positive urine
- •drug screen for Parkinson*s disease related medication is allowed at the
- •discretion of the PI.
- •8. Willing and able to abstain from alcohol 24 hours prior to each CHDR visit.
- •Negative alcohol breath test at screening and pre-dose.
- •9. Must be capable to communicate in the Dutch language.
- •10. Signed informed consent prior to any study-mandated procedure.
排除标准
- •1. History, signs or symptoms suggesting the diagnosis of secondary or atypical
- •parkinsonism.
- •2. Previous intolerance, potentially relevant interaction of co-medication with
- •or contraindication to levodopa and/or carbidopa.
- •3. Evidence of any active or chronic disease or condition that could interfere
- •with, or for which the treatment of might interfere with, the conduct of the
- •study, or that would pose an unacceptable risk to the subject in the opinion of
- •the investigator (following a detailed medical history, physical examination,
- •vital signs (systolic and diastolic blood pressure, pulse rate, body
- •temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the
- •normal range may be accepted, if judged by the Investigator to have no clinical
- •4. Clinically significant abnormalities, as judged by the investigator, in
- •laboratory test results (including hepatic and renal panels, complete blood
- •count, chemistry panel and urinalysis). In the case of uncertain or
- •questionable results, tests performed during screening may be repeated before
- •randomization to confirm eligibility or judged to be clinically irrelevant for
- •healthy subjects.
- •5. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
- •or human immunodeficiency virus antibody (HIV Ab) at screening.
- •6. Last dosing in a previous investigational drug study within 3 months prior
- •to first dosing of this study.
- •7. Any known factor, condition, or disease that might interfere with treatment
- •compliance, study conduct or interpretation of the results such as drug or
- •alcohol dependence or psychiatric disease.
- •8. Female patients who are pregnant, trying to become pregnant, or nursing
- •(lactating) an infant.
- •9. Having a levodopa equivalent dose of the morning medication that exceeds 500
- •10. Subjects that test positive for a SARS-CoV-2 infection
- •11. Subjects with a BMI > 30 and/or cardiovascular, respiratory or immune
- •system disorders
研究者
相似试验
招募中
2 期
Investigating the effect of synbiotics on uremic toxin concentrations in the pre-dialysis population.Renal and Urogenital - Kidney diseaseDiet and Nutrition - Other diet and nutrition disordersChronic Kidney DiseaseACTRN12613000493741Princess Alexandra Hospital40
进行中（未招募）
1 期
Validation of finger tapping in PD patientsMedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disordersParkinson's DiseaseEUCTR2020-000686-16-NLCentre for Human Drug Research20
已完成
4 期
Randomized, double-blind, placebo-controlled crossover study of ejaculatory disorder caused by orally administered silodosin in healty volunteer meJapanese healthy volunteer menJPRN-UMIN000000839Graduate school of medicine, Juntendo University50
进行中（未招募）
1 期
orediplon in adult patients with insomnia disorderEUCTR2014-001966-87-HRFERRER INTERNACIONAL, S.A.130
进行中（未招募）
1 期
orediplon in adult patients with insomnia disorderEUCTR2014-001966-87-PLFERRER INTERNACIONAL, S.A.130