A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND

Conditions: Parkinson s disease
MedDRA version: 8.1Level: LLTClassification code 10061536Term: Parkinson's disease

Registration Number: EUCTR2006-004112-51-IT

Lead Sponsor: VERNALIS DEVELOPMENT LIMITED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures