E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To correlate plasma levels of levodopa with ON time. To further characterize the safety profile for each treatment. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |