Parkinson s disease MedDRA version: 8.1 Level: LLT Classification code 10061536 Term: Parkinson's disease
Conditions
Interventions
Trade Name: SIRIO*30CPR EFF 25MG+100MG
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: Melevodopa and decarboxylase inhibitor
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
VERNALIS DEVELOPMENT LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 30 to 70 years of age of any race; 2. A Body Mass Index between 18.5 and 29.9 kg/m2 inclusive ; 3. Clinical diagnosis according to the Brain Bank diagnostic criteria of idiopathic Parkinson s Disease 2 of 3 cardinal symptoms - bradykinesia, rigidity, tremor -must be present, with a positive response to L-dopa ; 4. Presence of fluctuations in motor performance with 3 9 hours inclusive of daytime OFF episodes; 5. At least 1 hour delay to ON time with afternoon doses; 6. Discontinued use of COMT inhibitors cathecol-o-methyl transferase for at least 2 weeks prior to study entry; 7. Stable doses of dopamine agonists or selegiline for at least 2 weeks before entry into the study; 8. Stable comorbidity for 4 weeks; 9. Female patients must be of non-childbearing potential post-menopausal or physically incapable of childbearing ; 10. Willing and able to give informed consent according to national legal requirements prior to initiation of any study-related procedures. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinically relevant abnormal vital signs values, safety laboratory data or physical examination findings 2. Patients who smoke and are unable to refrain from smoking during the in-clinic period 3. Diagnosis of atypical parkinsonism; 4. A history and/or the presence of gastro-intestinal disorders or surgery that could interfere with absorption of the test medication; 5. A history of intolerance or clinically relevant allergy to L-dopa and/or carbidopa taken in any formulation or combination; 6. Any other condition which, in the opinion of the Investigator, would interfere with optimal participation in the study e.g. inability to complete patient diary; 7. Participation in any clinical study or receiving treatment with another investigational drug within 30 days or 5 half lives whichever is longer before the screening visit; 8. Blood donation within 3 months before study participation; 9. History of neuroleptic malignant syndrome NMS or NMS-like syndromes, or non-traumatic rhabdomyolysis; 10. Patients taking non-selective MAO inhibitors; 11. Patients with a history of, or clinical indication of, narrow angle glaucoma; 12. Patients with a history of, or clinical indication of, malignant melanoma; 13. Patients with a history of, or clinical indication of, depression or psychosis; 14. Patients taking iron containing medications ferrous sulphate, ferrous gluconate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine levodopa plasma level after repeated doses of V1512 in fluctuating PD patients, compared to standard levodopa/carbidopa Sinemet over the course of the day.;Secondary Objective: To correlate plasma levels of levodopa with ON time. To further characterize the safety profile for each treatment.;Primary end point(s): Pharmacokinetic PK evaluation will take place with regard to the following parameters for L-dopa and carbidopa, for each dose administration Cmax; Tmax; AUC0-t. The following pharmacodynamic parameters will be recorded or derived Motor category based on information recorded in the diary cards; troublesome dyskinesia as recorded in the diary cards; UPDRS section III motor component; Preference test | — |
Countries
Italy
Outcome results
None listed