Inclusion Criteria:

• 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 4 weeks prior to screening.
•A minimum of 3 hours awake “off-time” for each diary day recorded during the
baseline period.
•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
randomization and one month following completion of the study. Acceptable
contraceptive methods include abstinence, oral contraception, injectable
progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous
contraceptive patches, surgical sterilisation, male partner sterilization, intrauterine
device [IUD], or double barrier method: condom or occlusive cap (diaphragm or
cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository.
•Provide written informed consent for this study.
•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 diphasic
dyskinesia on their stable dose of L-dopa
•Consumption of any dopamine agonist, including ropinirole, within four weeks of
randomization in the study.
•Subjects 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, haematological, renal, hepatic, endocrinology,
neurological [other than Parkinson’s disease], cardiovascular, or active malignancy
[other than basal cell carcinoma]).
•Subjects with crippling degenerative arthritis or other physical or mental conditions
which would preclude accurate assessment of efficacy or safety.
•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].
•Subjects with severe clinical dementia e.g. scoring 3 or 4 on UPDRS item 1
[mentation].
•Subjects with severe dizziness or fainting due to postural hypotension on standing.
•Subjects with a personal history of melanoma.
•Subjects with clinically significant abnormalities in laboratory or ECG tests at
Screening. If findings are outside the normal range and the subject is included, it
must be documented by the investigator that the findings are not of clinical
significance.
•Subjects who are diagnosed with an impulse control disorder. The modified MIDI
will be conducted at screening. Subjects who score positive for this screen must be
referred to a specialist for diagnostic evaluation.
•Subjects who have an active suicidal plan/intent or have had active suicidal thoughts
in the past 6 months. Subjects who have a history of suicide attempt in the last 2
years or more than 1 lifetime suicide attempt.
•Current alcohol or drug dependence.
•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 (randomization). 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 (randomization) through the end of the treatment period.
•Women who are pregnant or breast-feeding.
•Use of an investigational drug from 30 days or 5 half-lives (whichever is longer)
prior to enrolment (randomization) through to the end of the treatment period.
15. Women who are pregnant or breast-feeding.
16. Use of an investigational drug from 30 days or 5 half-lives (whichever is longer)
prior to enrolment (randomization) through to the end of the treatment period.

• United States (click to view all sites in United States)
• Virginia (click to view)
• GSK Investigational Site
  Richmond, Virginia, 23249; RECRUITING;
  Contact: Mark Baron, Principal Investigator, .