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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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15 April 2024 |
Main ID: |
NCT02763137 |
Date of registration:
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26/04/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients
LDCD-001 |
Scientific title:
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A Phase IIa Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Efficacy of Intermittent Oral Administration of Standard Levodopa/Carbidopa vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Patients With Advanced Parkinson's Disease Who Suffer Motor Fluctuations |
Date of first enrolment:
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July 30, 2014 |
Target sample size:
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18 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT02763137 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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FABRIZIO STOCCHI, PROFESSOR |
Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS San Raffaele |
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Key inclusion & exclusion criteria
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Inclusion criteria
1. PD diagnosis consistent with United Kingdom Brain Bank Criteria
2. Good response to levodopa with at least 2 hours of wearing off episodes in judgment of
investigator
3. Stable doses of levodopa plus/minus other dopaminergic therapy (minimum of 4 weeks for
each drug)
4. Mini Mental Score Examination (MMSE): score > 26
5. Capable of providing informed consent
6. No clinically significant medical, psychiatric or laboratory abnormalities in the
judgment of the investigator.
7. No history of psychosis or hallucinations in the past 6 months
8. Women who are capable of child bearing must have a negative urine pregnancy test at
screening visit and use an adequate contraceptive method throughout the study.
9. Approval for entry into the study by an enrolment steering committee
Exclusion criteria
1. Atypical or secondary parkinsonism
2. Severe dyskinesia that might interfere with study performance in judgment of
investigator
3. Patient receiving duodopa, apomorphine infusion or Deep Brain Stimulation (DBS)
4. Dysphagia or sialorrhea that might interfere with administration of study intervention
5. Any relevant medical, surgical, or psychiatric condition, laboratory value, or
concomitant medication which, in the opinion of the Investigator, would interfere with
performing a pharmacokinetic study or would interfere with drug absorption.
Age minimum:
35 Years
Age maximum:
75 Years
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: Semi continuous intra-oral administration of LD/CD
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Drug: Standard LD/CD
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Primary Outcome(s)
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Variability in the observed plasma concentration of levodopa as assessed with the fluctuation index (Fluctuation index= (Maximum Plasma Concentration (Cmax)-Minimum Plasma Concentration (Cmin))/Concentration average)
[Time Frame: Change in fluctuation index between Day 2 and Day 3]
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Secondary Outcome(s)
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Assess the effect on UPDRS of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD
[Time Frame: Change in UPDRS between Day 2 and Day 3]
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Assess the safety and tolerability of continuous intra-oral administration of LD/CD: Adverse Events
[Time Frame: From Day 1 to Day 18]
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Assess the effect on number of hours of "off" time of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD
[Time Frame: Change in number of hours of "off" time between Day 2 and Day 3]
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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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