Clinical trial NCT01154166 (phase 3, status: completed)
Conditions: parkinson disease
ICD codes: G20
Drugs: requip pr, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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).