Parkinson's Disease MedDRA version: 14.1 Level: LLT Classification code 10013113 Term: Disease Parkinson's System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: REQUIP*28CPR 8MG R.P.
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: ROPINIROLE
CAS Number: 91374-21-9
Current Sponsor code: NA
Other descriptive name: NA
Concen
Sponsors
CASA DI CURA PRIVATA S.RAFFAELE - PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: Diagnosis of idiopathic Parkinson’s disease (according to modified Hoehn & Yahr criteria Stages I-IV) Subjects ia a stable DA agonists dose regimen for at least 18 months Subjects provided written informed consent for the study. Subjects are willing and able to comply with study procedures, including diary card completion and follow-up clinic visits. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Late stage advanced subjects demonstrating incapacitating dyskinesias 2. Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, haematological, renal, hepatic, endocrinological, neurological (other than Parkinson’s disease), or cardiovascular disease or active malignancy (other than basal cell cancer). 3. Any abnormality, at screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG. 4. Recent history of severe dizziness or fainting due to postural hypotension on standing. 5. Clinical dementia that in the judgment of the investigator would preclude assessment of the subject. 6. Subjects with neurotic behaviour, crippling degenerative arthritis or limb amputations, which would preclude efficacy or safety assessments. 7. Subjects with prior or current major psychosis (e.g. schizophrenia or psychotic depression) e.g., scoring 3 or 4 on UPDRS item 2 (thought disorder) or item 3 (depression). 8. Recent history or current evidence of drug abuse or alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The PK profile of Ropinirole PR allows a continuous dopaminergic stimulation at receptors D2/D3 that could be translated - in a clinical setting- in an improved efficacy in reducing the wearing off time versus the DA agonists immediate release. The rational of this study is to evaluate the effect of ropinirole 24h prolonged release (Ropinirole PR) on wearing OFF induced by dopamine agonist’s immediate release (Ropinirole IR, Pramipexole IR);Secondary Objective: Mean change from baseline in the PDQ39 Mean change from baseline in Parkinson’s Disease Sleep Scale. Proportion of subjects with a score of much improved or very much improved on the CGI-I scale Mean change from baseline in the UPDRS - Motor Score Mean change from baseline in the UPDRS - Activities of Daily Living Adverse events incidence rate;Primary end point(s): • Change from baseline in absolute awake time spent “off”;Timepoint(s) of evaluation of this end point: baseline and after 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean change from baseline in the PDQ39 Mean change from baseline in Parkinson’s Disease Sleep Scale. Proportion of subjects with a score of much improved or very much improved on the CGI-I scale Mean change from baseline in the UPDRS - Motor Score Mean change from baseline in the UPDRS - Activities of Daily Living Adverse events incidence rate;Timepoint(s) of evaluation of this end point: baseline and after 2 months | — |
Countries
Italy
Contacts
Public ContactCTC Fabrizio Stocchi
IRCCS San Raffaele Pisana
Outcome results
None listed