Parkinson Disease Clinical Trial
Official title:
An Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's Disease
The purpose of this study is to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients.
Status | Not yet recruiting |
Enrollment | 12 |
Est. completion date | January 2019 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: 1. diagnosis of PD consistent with UK Brain Bank Criteria 2. Stable dose of levodopa/carbidopa IR for at least 4 weeks prior to entry; taking at least 4 doses of IR levodopa during waking hours, and total daily dose of at least 400mg prior to initial screening 3. Stable on all anti-PD medications for 30 days prior to screening. COMT inhibitors are held prior to PK studies on day 1 through day 8 Exclusion Criteria: 1. Atypical or secondary parkinsonism 2. clinically significant cardiac, pulmonary, hepatic, or renal disease or other condition which contraindicates participation in judgement of investigator 3. severe dyskinesia as assessed by PI 4. significant cognitive impairment 5. Clinically significant psychiatric illness in opinion of PI 6. history of small bowel or gastric surgery (including PEG-J placement for Duopa/Duodopa) or bowel obstruction, diagnosis of small bowel narrowing, diagnosis of Crohn's disease, frequent nausea or emesis regardless of etiology, and symptomatic gastroparesis. 7. History of GI pathology of clinical significance as determined by PI 8. Allergy to study drug or Yellow Dye #5 (tartrazine) 9. Unable to swallow large pills 10. Active GERD and regular use of PPIs 11. Women who are pregnant or nursing or are of childbearing potential who are not willing to use a medically acceptable method of contraception |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Intec Pharma Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variability in plasma levodopa concentration | as assessed by levodopa fluctuation index (comparison of AP-CD/LD to IR-CD/LD | Pk blood sampling to be performed time 0 and every 30 minutes for 16 hours and again at 24 hours on days 1 and 8. | |
Secondary | Variability in plasma levodopa concentration | as assessed by Coefficient of variation (CV) (comparison of AP-CD/LD to IR-CD/LD) | Pk blood sampling to be performed time 0 and every 30 minutes for 16 hours and again at 24 hours on days 1 and 8. |
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