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An Open-Label Continuation Study Evaluating the Long-Term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease
This study is ongoing, but not recruiting participants.
Study NCT00632736   Information provided by GlaxoSmithKline
First Received: March 4, 2008   Last Updated: May 21, 2009   History of Changes

March 4, 2008
May 21, 2009
February 2004
December 2008   (final data collection date for primary outcome measure)
To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson''''s disease.
To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson''s disease.
Complete list of historical versions of study NCT00632736 on ClinicalTrials.gov Archive Site
  • 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.
To collect patient preference data regarding once daily versus three times daily dosing.
 
An Open-Label Continuation Study Evaluating the Long-Term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease
An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169.

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

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Parkinson's Disease
Drug: Ropinirole XL (formerly CR)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
419
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Czech Republic,   France,   Hungary,   Italy,   Poland,   Spain,   United Kingdom
 
NCT00632736
Study Director, GSK
101468/248
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP