Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI
- Conditions
- Parkinson's Disease aggravatedMedDRA version: 7.0Level: LLTClassification code 10034006
- Registration Number
- EUCTR2005-000314-12-DE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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).
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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: To assess the local ( sublingual) and general acceptability of the different doses of S 90049 ( one sublingual administration t.i.d for 14 days).;Primary end point(s): Primary parameters will be:<br>- time to turn ON,<br>- duration of the ON phase.
- Secondary Outcome Measures
Name Time Method