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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03576638 |
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Date of registration:
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25/06/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients
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Scientific title:
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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 |
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Date of first enrolment:
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July 2018 |
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Target sample size:
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12 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03576638 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Contacts
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Name:
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Fabrizio Stocchi, MD, PhD |
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Address:
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Telephone:
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+39 0652252311 |
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Email:
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fabrizio.stocchi@sanraffaele.it |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: Accordion Pill Carbidopa/Levodopa
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Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet
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Primary Outcome(s)
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Variability in plasma levodopa concentration
[Time Frame: 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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Secondary Outcome(s)
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Variability in plasma levodopa concentration
[Time Frame: 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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Secondary ID(s)
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2018-001209-95
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IN 18001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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