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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00632736

Purpose

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

Condition	Intervention	Phase
Parkinson's Disease	Drug: Ropinirole XL (formerly CR)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169.

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Ropinirole hydrochloride Ropinirole

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	419
Study Start Date:	February 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632736

Show 75 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	101468/248
Study First Received:	March 4, 2008
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00632736 History of Changes
Health Authority:	United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines; Hungary: National Institute of Pharmacy; Czech Republic: State Institute for Drug Control; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Parkinson's disease
open-label
long term safety
REQUIP
ropinirole IR

ropinirole CR
ropinirole XL
safety
efficacy

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Antiparkinson Agents
Dopamine Agonists

Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009