parkinson's disease MedDRA version: 9.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's
Conditions
Interventions
Trade Name: REQUIP-LP
Product Name: ropinirole
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: REQUIP
Product Name:
Sponsors
CHU de Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients = 30 and 24 • Stable dose of anti-Parkinsonian drug treatment including in addition to L-dopa: ReQuiP® IR, COMT inhibitors, selegiline, anticholinergics, amantadine for at least 1 month prior to inclusion; • All antiparkinsonian medications (other than REQUIP) expected to remain stable for the entire trial duration • Signed written informed consent by the patient to participate in the study and willingness and capacity to comply with all study procedures and scheduled visits, • Resident of France and fully insured 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: - Subjects with significant history of unstable medical illness over the last 30 days or with severe, clinically significant condition(s) other than Parkinson’s disease which, in the opinion of the investigator, would render the subject unsuitable for the study (e.g. psychiatric (including previous hallucinations or psychotic symptoms within the previous 3 months), haematological, renal, hepatic, endocrinology, neurological [other than Parkinson’s disease], cardiovascular, or active malignancy); -Neurosurgical intervention for Parkinson’s disease (e.g. pallidotomy, thalamotomy, transplantation and deep brain stimulation) within less than one year before screening; - Current use (or within 3 months before enrolment) unauthorized concomitant treatments (classical or atypical neuroleptics; anti-emetic drugs with D2 receptor antagonistic properties such as metoclopramide, not including domperidone; budipine, riluzole, dextromethorphan, memantine); - Co-treatment with other dopamine agonist than ropinirole; - Antidepressants/anxiolytics/hypnotics treatment which has not been at a stable dose for at least 1 month prior to the study (dose has to remain stable during the study); - Modafinil/psychostimulants consumption within the 3 months preceding enroilment - participation in another trial of an investigational drug within the past 30 days (or within kess than 5 plasma elimination half-life); - Probable depressive symptoms (Hospital Anxiety Depression Scale > 11); - Significant cognitive impairment as defined by MMSE score ? 24, DSMIV criteria for dementia, or more generally limited mental capacity or psychiatric disease rendering the subject unable to provide written informed consent or comply with evaluation procedures; - History of recent (past two years) alcohol or drug abuse; - History of non-adherence with treatment or other experimental protocols; - Definite or suspected personal or family history of clinically significant adverse reactions or hypersensitivity to ropinirole (or to drugs with a similar chemical structure) that would preclude long-term dosing with ropinirole; - Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g. ciprofloxacine, fluvoxamine,cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Subjects already on chronic therapy with any of these agents may be enrolled but doses must have remained stable from 7 days prior to enrolment through the end of the treatment period (liver interaction); - Suspected inability to complete the study follow-up (foreign workers, transient visitors, tourists or any others for whom follow-up evaluation is not assured); - Female of childbearing potential (apart of patients using adequate contraceptive measures), pregnant or breast feeding; - Patients under legal guardianship ;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of REQUIP® CR and IR on the discomfort induced by global daytime somnolence in PD patients suffering from REQUIP® IR induced daytime somnolence. ;Secondary Objective: To compare the effect of REQUIP® CR and IR on PD patients on other aspects of abnormal daytime somnolence and motor function; To assess safety and tolerability of REQUIP® CR versus REQUIP® IR. ;Primary end point(s): 7-points scale monitoring subjective discomfort induced by daytime somnolence in report to the previous week (the choice of this seven point subjective scale is driven by the fact that it is expected to be more sensitive to change in a single patient that other validated scale such as for example the ESS). | — |
Countries
France
Outcome results
None listed