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

NCT00355641 | Completed Phase 3

• 1 other identifier: 101468/206
• Study Type: interventional
• Target: 450
• Locations: 2 countries
• Sites: 65

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.

Conditions

Restless Legs Syndrome

Keywords

Ropinirole; Restless Legs Syndrome; RLS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

• Incidence and severity of adverse events.

  Up to 52 Weeks

• Changes in vital signs (blood pressure and pulse) and weight.

  Up to 52 Weeks

• Changes in laboratory assessments (hematology and clinical chemistry).

  Up to 52 Weeks

• Changes in electrocardiogram (ECG) parameters.

  Up to 52 Weeks

Study Arms (1)

Open Label

EXPERIMENTAL

All subjects will receive ropinirole XR in this study. The total daily dose range of ropinirole XR will be 0.5mg to 6.0mg daily

Drug: Ropinirole Extended Release (XR)

Interventions

Ropinirole Extended Release (XR) DRUG

Dose range of Ropinirole XR of 0.5mg to 6.0mg daily

Open Label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects in North America ≥18 years of age who
• Have successfully completed one of the following parent studies: 101468/205, ROX104805; OR
• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (65)

GSK Investigational Site

Alabaster, Alabama, 35007, United States

Location

GSK Investigational Site

Jasper, Alabama, 35501, United States

Location

GSK Investigational Site

Mesa, Arizona, 85201, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85050, United States

Location

GSK Investigational Site

Sun City, Arizona, 85351, United States

Location

GSK Investigational Site

Laguna Hills, California, 82653, United States

Location

GSK Investigational Site

Northridge, California, 91325, United States

Location

GSK Investigational Site

Oxnard, California, 93030, United States

Location

GSK Investigational Site

Pasadena, California, 91106, United States

Location

GSK Investigational Site

Redondo Beach, California, 90277, United States

Location

GSK Investigational Site

Reseda, California, 91355, United States

Location

GSK Investigational Site

San Diego, California, 92103, United States

Location

GSK Investigational Site

Santa Monica, California, 90404, United States

Location

GSK Investigational Site

Colorado Springs, Colorado, 80909, United States

Location

GSK Investigational Site

Denver, Colorado, 80212, United States

Location

GSK Investigational Site

Wheat Ridge, Colorado, 80033, United States

Location

GSK Investigational Site

Boca Raton, Florida, 33486, United States

Location

GSK Investigational Site

Largo, Florida, 33773, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33701, United States

Location

GSK Investigational Site

Stuart, Florida, 34996, United States

Location

GSK Investigational Site

Tampa, Florida, 33609, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30338, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Austell, Georgia, 30106, United States

Location

GSK Investigational Site

Dawsonville, Georgia, 30534, United States

Location

GSK Investigational Site

Macon, Georgia, 31201, United States

Location

GSK Investigational Site

Woodstock, Georgia, 30189, United States

Location

GSK Investigational Site

Oak Brook, Illinois, 60523, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66214, United States

Location

GSK Investigational Site

Topeka, Kansas, 66606, United States

Location

GSK Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

GSK Investigational Site

Springfield, Massachusetts, 01104, United States

Location

GSK Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89119, United States

Location

GSK Investigational Site

Cherry Hill, New Jersey, 08003, United States

Location

GSK Investigational Site

Toms River, New Jersey, 08755, United States

Location

GSK Investigational Site

Endwell, New York, 13760, United States

Location

GSK Investigational Site

New York, New York, 10021, United States

Location

GSK Investigational Site

Schenectady, New York, 12308, United States

Location

GSK Investigational Site

Greenville, North Carolina, 27834, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27607, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44130, United States

Location

GSK Investigational Site

Columbus, Ohio, 43232, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Medford, Oregon, 97504-8456, United States

Location

GSK Investigational Site

Portland, Oregon, 97210, United States

Location

GSK Investigational Site

Columbia, South Carolina, 29201, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Jackson, Tennessee, 38305, United States

Location

GSK Investigational Site

Dallas, Texas, 75231, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84107, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84121, United States

Location

GSK Investigational Site

Alexandria, Virginia, 22311, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22911, United States

Location

GSK Investigational Site

Spokane, Washington, 99204, United States

Location

GSK Investigational Site

Tacoma, Washington, 98405, United States

Location

GSK Investigational Site

Walla Walla, Washington, 99362, United States

Location

GSK Investigational Site

Wenatchee, Washington, 98801, United States

Location

GSK Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

Location

GSK Investigational Site

Langley, British Columbia, V3A 4H9, Canada

Location

GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2T 2N6, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

GSK Investigational Site

Regina, Saskatchewan, S4P 0W5, Canada

Location

Related 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).

  BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2006
• First Posted: July 24, 2006
• Study Start: October 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (59); CA (6)