Parkinson's disease
Conditions
Interventions
Levodopa/carbidopa 100/25 mg, over-encapsulated oral tablets or placebo.
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpoints 1. AFTT 2. Repetitive finger tapping 3. MDS-UPDRS III | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
Netherlands
Outcome results
None listed