An Open-Label Continuation Study Evaluating the Long-Term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease

Condition(s) targeted: Parkinson's Disease

Intervention: Ropinirole XL (formerly CR) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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

Official title: An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169.

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Secondary outcome:

To collect patient preference data regarding once daily versus three times daily dosing.

Additionally, patient preferences with regards to once daily versus three times daily dosing will be summarised.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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 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.

GSK Clinical Trials Call Centre, Bruxelles 1200, Belgium

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GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

GSK Clinical Trials Call Center, Durham, North Carolina 27709, United States

Starting date: February 2004
Ending date: December 2008
Last updated: March 28, 2008