GSK: Protocol Summary for 101468/206

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Protocol Summary for 101468/206

Protocol Summary
Protocol Id:	101468/206
Secondary Ids:	SK&F-101468/206
Title:	A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS)
Phase:	phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	yes
IND/IDE Grantor:	CDER
IND/IDE Number:	70,140
IND/IDE Serial Number:	0009
Has Expanded Access?:
Study Type:	Interventional
Oversight Authority:	United States: Food and Drug Administration Canada: Health Canada
Collaborators:
Brief Summary:	The primary objective of this study is to assess the safety and tolerability of ropinirole XR in the long-term treatment (up to 52 weeks)of adults with RLS.
Detailed Description:
Record Verification Date:	January 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	October 2005
Study Completion Date:	October 2007
Study Completion Date Type:	Actual
Primary Completion Date:	October 2007
Primary Completion Date Type:	Actual
Primary Purpose:	treatment
Allocation:	Non-randomized
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Single Group Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Incidence/severity of adverse events Changes in vital signs Labs ECG Assessment of augmentation and rebound (worsening of RLS symptoms).
Secondary Outcomes:	Incidence and severity of adverse events. CGI Severity of Illness (CGI-S) at Week 52 LOCF. Proportion of subjects satisfied with their treatment at Week 52 LOCF. Changes in electrocardiogram (ECG) parameters. Change from baseline in the domains of the Medical Outcomes Study (MOS-12) Sleep Scale at Week 52 LOCF. Change from baseline in the IRLS Rating Scale total score at Week 52 LOCF (last observation carried forward). Changes in laboratory assessments (hematology and clinical chemistry). Change from baseline in IRLS Rating Scale total score CGI Scale scores Medical Outcomes Study Sleep Scale scores Other subject-reported health outcomes. Change from baseline in the total score and domains of the Profile of Mood States (POMS) Scale Short Form at Week 52 LOCF. Change from baseline in the parameters for the work Productivity and Activity Impairment – Specific Health Problem (WPAI-SHP) Questionnaire at Week 52 LOCF. Proportion of subjects with a score of much improved (2) or very much improved (1) on CGI-I at Week 52 LOCF. Change from baseline in the overall life impact score of the RLS Quality of Life Questionnaire at Week 52 LOCF. Change from baseline in the anxiety and depression domains of the Hospital Anxiety and Depression (HADS) Scale at Week 52 LOCF. Changes in vital signs (blood pressure and pulse) and weight. Assessment of augmentation. Assessment of rebound.
Conditions:	Restless Legs Syndrome
Keywords:	Ropinirole Restless Legs Syndrome RLS
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion criteria: •A subject will be eligible for inclusion in this study only if all of the following criteria apply: •Subjects in North America ≥18 years of age who a.Have successfully completed one of the following parent studies: 101468/205, ROX104805; OR b.Have a diagnosis of primary RLS using the International RLS Study Group (IRSSG) Diagnostic Criteria (Appendix 10), experience RLS symptoms during both the evening (before 8 PM) and night-time, and have a total score ≥15 on the IRLS Rating Scale at Baseline. Subjects must have a history of a minimum of 20 evenings/nights of RLS episodes per month (e.g., any combination of evenings and/or nights for ≥ 20 days). During Screening/Washout, RLS symptoms must be present for at least 4 of 7 evenings/nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for ≥ 4 days). •Subjects must give written informed consent prior to any specific study procedures. Exclusion Criteria: •Subjects who have any medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis. •Subjects having clinically significant abnormal laboratory or ECG findings not resolved at time of baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias. •Subjects with a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg or systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at the Screening or Baseline visit. •Subjects with a history of augmentation and/or end-of-dose rebound symptoms. ·Augmentation is defined as RLS symptoms that occurred while on treatment and occur ≥ 2 hours earlier than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body, such as the arms or trunk. ·End-of-dose rebound is defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication. •Subjects who have exhibited intolerance to ropinirole. •For subjects entering Study 206, certain medications must be discontinued prior to entering the study. The following medications are prohibited for the duration of the study period which is up to and including the Follow-up visit: ·dopamine agonists (including ropinirole immediate release formulation), dopamine antagonists (e.g., typical neuroleptics, metoclopramide), levodopa/carbidopa The minimum discontinuation period is generally 5 half-lives or 7 consecutive evening/nights medication-free, prior to baseline, whichever is the longer period. If the subject will require longer than 2 weeks following the Follow-up visit of the parent study to complete the washout, GSK must be consulted for further instructions. •Other medications, including those with partial dopaminergic activity (e.g., atypical antipsychotics, certain antidepressants such as bupropion, tricyclic antidepressants and monoamine oxidase inhibitors) may have additive activity with ropinirole and should be used with caution in patients taking ropinirole. For patients on stable doses, these agents may be permitted; however, it is recommended that the dose of the medication remain stable throughout the duration of the study. •Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study. •Women who have a positive pregnancy test. •Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant). The following exclusion criteria must be assessed at Study 206 Screen/Baseline for subjects who are not rolling in following completion of Study 101468/205 or ROX104805: •Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g., narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder). •Subjects diagnosed with movement disorders (e.g., Parkinson's disease, dyskinesias, and dystonias). •Signs of secondary RLS (e.g., end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit) •Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM). •Subjects with a history of alcohol or substance abuse within the past year. •Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures •Participation in any clinical drug or device trial (other than Study 101468/205 or ROX104805) in the one month prior to the Baseline Visit
Gender:	Both
Minimum Age:	18 Year
Maximum Age:
Enrollment:	450
Enrollment Type:
Healthy Volunteers?:	none
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Canada (click to view all sites in Canada) GSK Investigational Site Coquitlam, British Columbia, V3K 3P4; COMPLETED; GSK Investigational Site Langley, British Columbia, V3A 4H9; COMPLETED; GSK Investigational Site Ajax, Ontario, L1S 2J5; COMPLETED; GSK Investigational Site Sherbrooke, Québec, J1H 1Z1; COMPLETED; GSK Investigational Site Montreal, Québec, H2T 2N6; COMPLETED; GSK Investigational Site Regina, Saskatchewan, S4P 0W5; COMPLETED; United States (click to view all sites in United States) Alabama (click to view) GSK Investigational Site Jasper, Alabama, 35501; COMPLETED; GSK Investigational Site Alabaster, Alabama, 35007; COMPLETED; Arizona (click to view) GSK Investigational Site Phoenix, Arizona, 85050; COMPLETED; GSK Investigational Site Sun City, Arizona, 85351; COMPLETED; GSK Investigational Site Mesa, Arizona, 85201; COMPLETED; California (click to view) GSK Investigational Site Laguna Hills, California, 82653; COMPLETED; GSK Investigational Site Redondo Beach, California, 90277; COMPLETED; GSK Investigational Site Pasadena, California, 91106; COMPLETED; GSK Investigational Site Reseda, California, 91355; COMPLETED; GSK Investigational Site Northridge, California, 91325; COMPLETED; GSK Investigational Site Santa Monica, California, 90404; COMPLETED; Colorado (click to view) GSK Investigational Site Colorado Springs, Colorado, 80909; COMPLETED; GSK Investigational Site Wheat Ridge, Colorado, 80033; COMPLETED; GSK Investigational Site Denver, Colorado, 80212; COMPLETED; Florida (click to view) GSK Investigational Site Stuart, Florida, 34996; COMPLETED; GSK Investigational Site Tampa, Florida, 33609; COMPLETED; GSK Investigational Site Boca Raton, Florida, 33486; COMPLETED; GSK Investigational Site Largo, Florida, 33773; COMPLETED; GSK Investigational Site St. Petersburg, Florida, 33701; COMPLETED; Georgia (click to view) GSK Investigational Site Austell, Georgia, 30106; COMPLETED; GSK Investigational Site Dawsonville, Georgia, 30534; COMPLETED; GSK Investigational Site Atlanta, Georgia, 30338; COMPLETED; GSK Investigational Site Atlanta, Georgia, 30342; COMPLETED; GSK Investigational Site Woodstock, Georgia, 30189; COMPLETED; GSK Investigational Site Atlanta, Georgia, 30342; COMPLETED; GSK Investigational Site Macon, Georgia, 31201; COMPLETED; Illinois (click to view) GSK Investigational Site Oak Brook, Illinois, 60523; COMPLETED; Kansas (click to view) GSK Investigational Site Lenexa, Kansas, 66214; COMPLETED; GSK Investigational Site Topeka, Kansas, 66606; COMPLETED; Louisiana (click to view) GSK Investigational Site Baton Rouge, Louisiana, 70808; COMPLETED; Massachusetts (click to view) GSK Investigational Site Springfield, Massachusetts, 01104; COMPLETED; Michigan (click to view) GSK Investigational Site Bingham Farms, Michigan, 48025; COMPLETED; Nevada (click to view) GSK Investigational Site Las Vegas, Nevada, 89119; COMPLETED; New Jersey (click to view) GSK Investigational Site Toms River, New Jersey, 08755; COMPLETED; GSK Investigational Site Cherry Hill, New Jersey, 08003; COMPLETED; New York (click to view) GSK Investigational Site Schenectady, New York, 12308; COMPLETED; GSK Investigational Site Endwell, New York, 13760; COMPLETED; North Carolina (click to view) GSK Investigational Site Greenville, North Carolina, 27834; COMPLETED; GSK Investigational Site Raleigh, North Carolina, 27607; COMPLETED; Ohio (click to view) GSK Investigational Site Columbus, Ohio, 43232; COMPLETED; GSK Investigational Site Cleveland, Ohio, 44130; COMPLETED; Oklahoma (click to view) GSK Investigational Site Oklahoma City, Oklahoma, 73112; COMPLETED; Oregon (click to view) GSK Investigational Site Medford, Oregon, 97504-8456; COMPLETED; GSK Investigational Site Portland, Oregon, 97210; COMPLETED; South Carolina (click to view) GSK Investigational Site Mount Pleasant, South Carolina, 29464; COMPLETED; GSK Investigational Site Columbia, South Carolina, 29201; COMPLETED; Tennessee (click to view) GSK Investigational Site Jackson, Tennessee, 38305; COMPLETED; Texas (click to view) GSK Investigational Site Dallas, Texas, 75231; COMPLETED; GSK Investigational Site San Antonio, Texas, 78229; COMPLETED; Utah (click to view) GSK Investigational Site Salt Lake City, Utah, 84107; COMPLETED; GSK Investigational Site Salt Lake City, Utah, 84121; COMPLETED; Virginia (click to view) GSK Investigational Site Charlottesville, Virginia, 22911; COMPLETED; GSK Investigational Site Alexandria, Virginia, 22311; COMPLETED; Washington (click to view) GSK Investigational Site Walla Walla, Washington, 99362; COMPLETED; GSK Investigational Site Spokane, Washington, 99204; COMPLETED; GSK Investigational Site Tacoma, Washington, 98405; COMPLETED; GSK Investigational Site Wenatchee, Washington, 98801; COMPLETED;

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Protocol Summary for 101468/206