E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Parkinson's Disease aggravated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034006 |
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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 |
The main objective of this trial is to assess the effect of 3 different doses ( 20, 40 and 60 mg) of a sublingual new formulation of piribedil in combination with L-dopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14-day treatment period. The main objective is to assess the effect of the 40 mg dose versus placebo.The two other comparisons will allow to demonstrate a discrimination between the different doses and to situate the 40 mg towards the 20 mg dose. |
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E.2.2 | Secondary objectives of the trial |
To assess the local ( sublingual) and general acceptability of the different doses of S 90049 ( one sublingual administration t.i.d for 14 days). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be men or women, aged 35 to 80 years, with idiopathic Parkinson's disease at the stage III or IV in "OFF" state according to the modified Hoehn and Yahr classification, with fluctuating resmpnses to L-Dopa ( end-of-dose akinesia). |
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E.4 | Principal exclusion criteria |
- Patients presenting complex, sudden ( switch "ON-OFF" or "OFF-ON" within 1 minute) and unpredictable "ON-OFF" phenomena, requiring a treatment with subcutaneous injections of apomorphine, - Patients requiring more than 7 administrations ( plus 1 administration in the evening) of levodopa per day, - Patients with history of invasive hallucinations ( non-critical, durable, threatening) and/or episodes of confusions, - Patients treated with neuroleptics ( antimetic and antipsychotic), - Patients treated with cabergoline in the previous 6 weeks due to its too long terminal half-life, - Patients with previous or current intolerance to piribedil, - Patients intolerant to lactose and aspartam, - Patients presenting a contra-indication to: Piribedil: hypersensitivity to piribedil, cardiovascular collapses, neuroleptic treatment, acute myocardial infarction, Motilium: gastrointestinal bleeding, intestinal perforation or mechanical obstruction, drug-induced late dyskinesia, - Patients with neurosurgery for Parkinson's disease, - Patients with a history of allergy or hypersensitivity, - Patients with symptomatic orthostatic hypotension, uncompensated heart, lung, kidney or endocrine disease, - Patients with severe and/or progressive following diseases: psychiatric disorders, psychosis, dementia or neurological disorders other than PD, - Patients with recent myocardial infarction ( within 6 months), clinical evidence of heart failure, unstable angina pectoris, - Pregnancy, breast-feeding or absence of effective contraception in women of child bearing potential, - Patients with serious concomitant disease ( e.g., progressive malignant neoplasm, poorly controlled diabetes,...), - Patients with known severe renal failure and hepatobilioary insufficiency. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary parameters will be: - time to turn "ON", - duration of the "ON" phase. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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 | No |
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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 28 |