Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Parkinson Disease

Treatments

Drug: Requip PR

Study type

Interventional

Funder types

Industry

Identifiers

NCT01536574

114463

Details and patient eligibility

About

This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.

Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.

Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.

Enrollment

295 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have completed 24 weeks of randomised treatment in study ROP111528(and must have completed the one-week downtitration at the end of treatment/early withdrawal).
Subjects must not have a break in medication between completing the downtitration phase for studies ROP111528 and beginning treatment in this extension study.
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

Patients with any ongoing clinically significant adverse events at the end of the study ROP111528.
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 study ROP111528.
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. 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 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.