Parkinson's Disease MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: SINEMET 125
Product Name: SINEMET
Product Code: RVG 08740
Pharmaceutical Form: Tablet
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Concentration unit: mg milligram(s)
Con
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 20-85 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. 9. Must be capable to communicate in the Dutch language. 10. Signed informed consent prior to any study-mandated procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Tolerability / safety endpoints There are no safety and tolerability endpoints for this study. However, (S)AEs occurring or worsening throughout the study will be recorded. Patients enrolled in this study already use levodopa, or have used it the past, so they are expected to tolerate the study treatment well. Pharmacodynamic endpoints 1. MDS-UPDRS III Part III of the MDS-UPDRS consists of a motor examination. In total 18 questions are assessed on speech, rigidity, finger tapping, hand movements, gait, posture and tremor (Goetz, 2010). The test takes approximately 15 minutes to complete. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. In total there are 33 scores based on 18 items, several with right, left or other body distribution scores. In addition, ON and OFF status assessment is associated with part III and ON/OFF status definitions are provided to ensure uniformity among raters. Endpoints will be total score and score per subset of questions. 2. AFTT The patients is asked to move the index finger, or the index and middle finger between two targets. The task is to tap as accurately and as fast as possible for the duration of 30 seconds. Endpoints will be inter-tap velocity, spatial error, total number of taps, inter-tap interval, rhythm, change in speed, inter-tap distance, absolute accuracy and tapping errors. 3. Repetitive finger tapping A wireless light-weight goniometer is placed on the index finger. The patient is instructed to tap the index finger on the thumb as quickly and as widely as possible. Subsequently, the angle of opening between these two fingers can be recorded during a repetitive finger tapping task. An advantage of the goniometer is that it enables quantification of movement amplitude and range of motion which is known to be impaired in PD patients. This application has been shown to differentiate betwee | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory endpoint Rating on the user experience questionnaire. The questionnaire assesses the usability and experiences with the finger tapping devices and tasks. ;Timepoint(s) of evaluation of this end point: Day -1 - EOS | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Centre for Human Drug Research
Outcome results
None listed