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

Phase 3

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: Ropinirole Extended Release (XR)

• Registration Number: NCT00355641
• Lead Sponsor: GlaxoSmithKline

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

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-07-20
• Study First Submitted QC: 2006-07-20
• Study First Posted: 2006-07-24
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label	Ropinirole Extended Release (XR)	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Assessment of augmentation.	Up to 52 Weeks
Assessment of rebound.	Up to 52 Weeks
Change from baseline in the IRLS Rating Scale total score at Week 52 LOCF (last observation carried forward).	Up to 52 Weeks
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
CGI Severity of Illness (CGI-S) at Week 52 LOCF.	Up to 52 Weeks
Change from baseline in the domains of the Medical Outcomes Study (MOS-12) Sleep Scale at Week 52 LOCF.	Up to 52 Weeks
Change from baseline in the overall life impact score of the RLS Quality of Life Questionnaire at Week 52 LOCF.	Up to 52 Weeks
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
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
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
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
Proportion of subjects satisfied with their treatment at Week 52 LOCF.	Up to 52 Weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇦 Regina, Saskatchewan, Canada