Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome

Restless Legs Syndrome Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355641
• Other study ID #: 101468/206
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2006
• Last updated: October 27, 2016
• Start date: October 2005
• Est. completion date: October 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

1. Have successfully completed one of the following parent studies: 101468/205, ROX104805; OR

2. 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

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Intervention

Drug:
• Ropinirole Extended Release (XR)
Dose range of Ropinirole XR of 0.5mg to 6.0mg daily

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Ajax	Ontario
Canada	GSK Investigational Site	Coquitlam	British Columbia
Canada	GSK Investigational Site	Langley	British Columbia
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Regina	Saskatchewan
Canada	GSK Investigational Site	Sherbrooke	Quebec
United States	GSK Investigational Site	Alabaster	Alabama
United States	GSK Investigational Site	Alexandria	Virginia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austell	Georgia
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Bingham Farms	Michigan
United States	GSK Investigational Site	Boca Raton	Florida
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Cherry Hill	New Jersey
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dawsonville	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Jackson	Tennessee
United States	GSK Investigational Site	Jasper	Alabama
United States	GSK Investigational Site	Laguna Hills	California
United States	GSK Investigational Site	Largo	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lenexa	Kansas
United States	GSK Investigational Site	Macon	Georgia
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Mount Pleasant	South Carolina
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Northridge	California
United States	GSK Investigational Site	Oak Brook	Illinois
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oxnard	California
United States	GSK Investigational Site	Pasadena	California
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Redondo Beach	California
United States	GSK Investigational Site	Reseda	California
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Santa Monica	California
United States	GSK Investigational Site	Schenectady	New York
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	Stuart	Florida
United States	GSK Investigational Site	Sun City	Arizona
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Toms River	New Jersey
United States	GSK Investigational Site	Topeka	Kansas
United States	GSK Investigational Site	Walla Walla	Washington
United States	GSK Investigational Site	Wenatchee	Washington
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

C Hill-Zabala, R Bogan, D Lee, M Lomax. A 52-week open-label study to assess the long-term tolerability of Ropinirole CR Extended Release Tablets in subjects with Restless Legs Syndrome (RLS). 12th International Congress of Parkinson's Disease and Movement Disorders, Chicago, IL, June 22-26, 2008 (abstract 1112).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence/severity of adverse events Changes in vital signs Labs ECG Assessment of augmentation and rebound (worsening of RLS symptoms).		Up to 52 Weeks
Secondary	Change from baseline in IRLS Rating Scale total score CGI Scale scores Medical Outcomes Study Sleep Scale scores Other subject-reported health outcomes.		Up to 52 Weeks
Secondary	Incidence and severity of adverse events.		Up to 52 Weeks
Secondary	Changes in vital signs (blood pressure and pulse) and weight.		Up to 52 Weeks
Secondary	Changes in laboratory assessments (hematology and clinical chemistry).		Up to 52 Weeks
Secondary	Changes in electrocardiogram (ECG) parameters.		Up to 52 Weeks
Secondary	Assessment of augmentation.		Up to 52 Weeks
Secondary	Assessment of rebound.		Up to 52 Weeks
Secondary	Change from baseline in the IRLS Rating Scale total score at Week 52 LOCF (last observation carried forward).		Up to 52 Weeks
Secondary	Proportion of subjects with a score of much improved (2) or very much improved (1) on CGI-I at Week 52 LOCF.		Up to 52 Weeks
Secondary	CGI Severity of Illness (CGI-S) at Week 52 LOCF.		Up to 52 Weeks
Secondary	Change from baseline in the domains of the Medical Outcomes Study (MOS-12) Sleep Scale at Week 52 LOCF.		Up to 52 Weeks
Secondary	Change from baseline in the overall life impact score of the RLS Quality of Life Questionnaire at Week 52 LOCF.		Up to 52 Weeks
Secondary	Change from baseline in the anxiety and depression domains of the Hospital Anxiety and Depression (HADS) Scale at Week 52 LOCF.		Up to 52 Weeks
Secondary	Change from baseline in the total score and domains of the Profile of Mood States (POMS) Scale Short Form at Week 52 LOCF.		Up to 52 Weeks
Secondary	Change from baseline in the parameters for the work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) Questionnaire at Week 52 LOCF.		Up to 52 Weeks
Secondary	Proportion of subjects satisfied with their treatment at Week 52 LOCF.		Up to 52 Weeks

External Links

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