Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson*s Disease patients.
- Conditions
- Parkinson's disease10028037
- Registration Number
- NL-OMON49757
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
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
levodopa.
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.
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
relevance.
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
mg.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method