Clinical Trial: Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Evaluation of Ropinirole CR-RLS Tablets in Restless Legs Syndrome-Open-Label, Uncontrolled Study. Classification: Clinical Pharmacolo

Brief Summary: This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Drug Related Adverse Events-On-Therapy [ Time Frame: Weeks 1 - 12 Treatment Period ]
  • Haematology Clinical Lab Values Change From Baseline [ Time Frame: Baseline - Week 13 (Follow-up) ]
    Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.
  • Blood Chemistry Clinical Lab Values Change From Baseline [ Time Frame: Baseline - Week 13 (Follow-up) ]
    Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L
  • Urinalysis Clinical Lab Values [ Time Frame: Baseline - Week 13 (Follow-up) ]
    Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.
  • 12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline [ Time Frame: Baseline, Week 4, 8, 12, 13 (Follow-up) ]
    Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.
  • Vital Signs and Body We

    Original Primary Outcome: Adverse events and Pharmacokinetics

    Current Secondary Outcome:

    • Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score [ Time Frame: Baseline and after Week 12 ]
      The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points.
    • Clinical Global Impression Scale - Severity of Illness (CGI-S) [ Time Frame: Baseline - Final assessment point ]
      The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7).
    • Clinical Global Impression Global Improvement (CGI-GI) [ Time Frame: Baseline - Final assessment point ]
      CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7).
    • Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score [ Time Frame: Baseline - Week 12/EW ]
      The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.
    • Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains [ Time Frame: Baseline - Week 12/EW ]
      The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.
    • Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score [ Time Frame: Baseline and Week 12/EW ]
      The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47
    • Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS) [ Time Frame: Baseline and Week 12/EW ]

      The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from "Not at all (0)" to "Extremely (4)." The assessment measures six identified mood factors:

      • Tension-Anxiety
      • Depression-Dejection
      • Anger-Hostility
      • Vigor-Activity
      • Fatigue-Inertia
      • Confusion-Bewilderment
    • Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline - Week 12/EW ]
      Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety "0-21" and seven for depression "0-21". Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation.
    • Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole. [ Time Frame: Weeks 1-12 ]
      Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.
    • Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole. [ Time Frame: Weeks 1 -12 ]
      Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.
    • Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole. [ Time Frame: Weeks 1-12 ]
      Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This

      Original Secondary Outcome: International RLS Rating Scale

      Information By: GlaxoSmithKline

      Dates:
      Date Received: September 14, 2007
      Date Started: August 2007
      Date Completion:
      Last Updated: January 16, 2017
      Last Verified: January 2017