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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-004112-51-IT
• Date of registration: 04/12/2006
• Prospective Registration: No
• Primary sponsor: VERNALIS DEVELOPMENT LIMITED
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 14/11/2006
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004112-51
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: yes Other: yes Other trial design description: Double dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Italy

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Parkinson s disease
MedDRA version: 8.1 Level: LLT Classification code 10061536 Term: Parkinson's disease

Intervention(s)

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: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Effervescent tablet
Route of administration of the placebo: Oral use

Trade Name: SINEMET*50CPR 100MG+25MG

Pharmaceutical Form: Tablet
INN or Proposed INN: LEVODOPA DC.IT FU
CAS Number: 59-92-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: CARBIDOPA FU
CAS Number: 28860-95-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

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 Objective: To correlate plasma levels of levodopa with ON time. To further characterize the safety profile for each treatment.

Secondary ID(s)

V1512-2PD01