A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa

This is an interventional treatment trial for Parkinson Disease Read More

Inclusion Criteria:

• 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 (such as 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]), during the study and for at least one month prior to randomisation and one month following completion of the study.
• 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)
• Subjects receiving a stable dose of L-dopa for at least four weeks prior to screening.
• Provide written informed consent for this study
• A minimum of 3 hours awake time"off " for each diary day recorded during the Placebo Run-In Period.
• Be willing and able to comply with study procedures, including diary card completion and follow-up clinic visits.

Exclusion Criteria:

• Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa.
• Presence, or history within the previous 3 months, of significant and/or uncontrolled psychiatric, hematological, renal, hepatic, endocrinological, neurological (other than Parkinson.s Disease), or cardiovascular disease or active malignancy (other than basal cell cancer);
• Any abnormality, at Screening, that the investigator deems to be clinically relevant on history, physical examination and in diagnostic laboratory tests including ECG;
• Unstable liver disease, cirrhosis, known biliary abnormalities(except Gilbert's syndrome or asymptomatic gallstones) or AST or ALT>2xULN or alk phos and bilirubin>1.5 xULN
• Recent history of severe dizziness or fainting due to postural hypotension on standing.
• Clinical dementia that in the judgment of the investigator would preclude assessment of the subject.
• Recent history or current evidence of drug abuse or alcoholism.
• Consumption of any dopamine agonist within four weeks of the screening visit.
• 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 PR.
• 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 must remain on stable doses of the agent from 7 days prior to enrolment through the end of the Treatment Period.
• Use of an investigational drug within 30 days or 5 half-lives (which ever is longer).