Parkinson's disease
Conditions
Interventions
Product Name: Ropinirole PR/XR Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Ropinirole
CAS Number: 91374-20-8
Current Sponsor code: SKF101468-A
Other descriptive name: Ropinirole hydrochlo
Sponsors
GlaxoSmithKline Research & Development Ltd
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: 1. Men or non-pregnant/non-breast-feeding women of at least 30 years of age at screening. Women of child-bearing potential must be practicing a clinically accepted method of contraception during the study and for at least one month prior to randomisation and one month following completion of the study. Acceptable contraceptive methods include oral contraception, surgical sterilization, intrauterine device [IUD], or diaphragm IN ADDITION to spermicidal foam and condom on male partner, or systemic contraception [i.e. Norplant System]. 2. Diagnosis of idiopathic Parkinson’s disease (according to modified Hoehn & Yahr criteria Stages II-IV) and demonstrating lack of control with L-dopa therapy (e.g. end of dose akinesia, simple “on”/”off” fluctuations). 3. Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to Baseline Period. 4. Subjects provided written informed consent for the study. 5. A minimum of 3 hours awake time “off” for each diary day was recorded during the Baseline Period. 6. 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: 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: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Late stage advanced subjects demonstrating incapacitating dyskinesias on their stable dose of L-dopa. 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. 9. Consumption of any dopamine agonist within 4 weeks of the screening visit. 10. 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 IR or PR/XR tablets. 11. Withdrawal, introduction, or change in dose of HRT and/or any drug known to substantially inhibit Cytochrome P 450 1A2 (CYP1A2 e.g. ciprofloxacin, 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 must remain on stable doses of the agent from 7 days prior to enrolment through the end of the treatment period. 12. Use of an investigational drug from 30 days prior to enrolment through to the end of the treatment period. 13. More than 12 hours “off” time recorded on any individual day during the Baseline Period. In France, a subject is neither affiliated with nor a beneficiary of a social security category (requirement for subjects recruited in France). The French subject has participated in any study using an investigational drug during the previous 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To evaluate the efficacy profile of ropinirole PR/XR tablets compared with ropinirole IR tablets as adjunctive therapy to L-dopa in subjects with Parkinson’s disease • To evaluate the safety profile of ropinirole PR/XR and IR tablets as adjunctive therapy to L-dopa in subjects with Parkinson’s disease ;Main Objective: To demonstrate the superiority of ropinirole PR/XR tablets over ropinirole IR tablets when used as adjunctive therapy to L-dopa in subjects with advanced stage Parkinson’s disease who are not adequately controlled on L-dopa.;Primary end point(s): Percent of subjects with at least a 20% maintained reduction in time “off” at endpoint - (this is defined as the percent of subjects with at least a 20% reduction from baseline in time “off” at endpoint [Week 24 LOCF] and the timepoint immediately preceding this endpoint). The general definition of time “off” includes a lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. | — |
Countries
Czech Republic, Germany, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed