An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease
Condition: Parkinson Disease; Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Ropinirole XL (formerly CR)
Intervention MeSH terms: Ropinirole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 419.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: ropinirole XL; REQUIP; Parkinson's disease; long term safety; efficacy; safety; ropinirole CR; ropinirole IR; open-label

Summary:

      To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with
      early and advanced Parkinson's disease
    

Eligibility criteria:

        Inclusion Criteria:

        A subject will be eligible for inclusion in this study only if all of the following
        criteria apply:

          -  Subjects must have completed REQUIP studies 165 or 168, or must have completed at
             least 12 weeks of randomised treatment in study 169 (and must have completed the
             one-week down titration at the end of treatment/early withdrawal).

          -  Subjects must not have a break in medication between completing the feeder study
             (including the down titration phase for studies 168 and 169) and beginning treatment
             in study 248.

          -  Women of child-bearing potential must be practicing a clinically accepted method of
             contraception during the study and for 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 (e.g. Norplant System).

          -  Provide written informed consent for this study.

          -  Be willing and able to comply with study procedures.

        Exclusion Criteria:

        A subject will not be eligible for inclusion in this study if any of the following criteria
        apply:

          -  Patients with any ongoing clinically significant adverse events at the end of the
             "feeder" studies.

          -  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, hematological, renal, hepatic, endocrinology,
             neurological (other than Parkinson's disease), cardiovascular, or active malignancy
             (other than basal cell carcinoma).

          -  Subjects with clinically significant abnormalities in Laboratory or ECG tests at the
             end of the feeder study (REQUIP study 165, 168 or 169).

          -  Subjects with severe dizziness or fainting due to postural hypotension on standing.

          -  Withdrawal, introduction, or change in dose of hormone replacement therapy 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 doses must have remained stable from 7 days
             prior to enrolment through the end of the treatment period.

          -  Women who are pregnant or breast-feeding.

          -  Use of an investigational drug throughout the treatment period.