Parkinson's Disease aggravated MedDRA version: 7.0 Level: LLT Classification code 10034006
Conditions
Interventions
Product Name: piribedil
Product Code: S 90049 - F36
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: piribedil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
Institut de Recherches Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
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 responses 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
Exclusion criteria
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 confusion, -Patients treated with neuroleptics (antimetic and antipsychotic), -Patients with previous or current intolerance to piribedil, -Patients presenting a contra-indication to: ¤Piribedil: hypersensitivity to piribedil, cardiovascular collapses, neuroleptic treatment, acute myocardial infraction, ¤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 hepatobiliary insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: -time to turn “ON”, -duration of the “ON” phase. | — |
Countries
Germany, Spain
Outcome results
None listed