Parkinson's disease patients who suffer motor fluctuations will participate in the study MedDRA version: 17.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: SINEMET 100 mg + 25 mg compresse
Product Name: SINEMET 100 mg + 25 mg compresse
Product Code: NA
Pharmaceutical Form: Oral suspension
Sponsors
SynAgile Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. PD diagnosis consistent with UK 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. 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. 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 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the plasma pharmacokinetics of continuous intra-oral administration of LD/CD vs. intermittent administration of standard oral LD/CD;Secondary Objective: To assess the safety and tolerability of continuous intra-oral administration of LD/CD To assess the effect on PD motor function of continuous intra-oral infusion of LD/CD vs. intermittent administration of standard oral LD/CD ;Primary end point(s): Pharmacokinetic: The primary outcome measure will be the variability in the observed plasma concentration of levodopa as assessed with the fluctuation index (Fluctuation index = (Cmax-Cmin)/Caverage). ;Timepoint(s) of evaluation of this end point: The hourly time points are as follows: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, and 8, on Days 2 and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetic: Secondary outcome measures will include assessment of variability using the coefficient of variation (CV). Exploratory measures will include assessments of levodopa Cmax, Tmax, and AUC. Plasma PK of carbidopa, HVA, DOPAC, and 3-OMD will also be assessed. Safety: Safety will be assessed by descriptive reporting of adverse events (frequency and severity) Tolerability: Tolerability will be assessed by percentage of subjects that complete the trial on given treatment assignment. Efficacy: Efficacy will be measured by the number of off hours in 8-hour day as determined by physician evaluations and in the change in the UPDRS between the baseline and mean of 2, 4, and 8-hour evaluations ;Timepoint(s) of evaluation of this end point: Pharmacokinetic :The hourly time points are as follows: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8, on Days 2 and 3 Safety: descriptively by D2, D3, and D4 and cumulative safety Tolerability: Baseline to D2, Baseline to D3 and Baseline to D4 Efficacy: every half hour over 8 hour period and at hours 2,4, and 8 | — |
Countries
Italy
Contacts
Public ContactMichela Pilone
CIRM
Outcome results
None listed