Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ropinirole controlled release-RLS · 1 trial · 1 indication
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.
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
Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.
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.
Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.
| Arm | Type | Description |
|---|---|---|
| ropinirole CR-RLS | EXPERIMENTAL | Subjects will orally take ropinirole CR-RLS tablet(s) once daily 1-2 hours before the onset of RLS symptoms at about the same time of the day. The time of taking ropinirole must be after 16:00.Adjustment of the Ropinirole CR-RLS tablets should be completed after the Week 1 visit up to the Week 10 visit. The dose will be increased at intervals of at least one week until sufficient efficacy is obtained (use "much improved" as a guide) without safety problem. Dose escalation will start at the initial dose 0.5 mg/day to 1 mg/day; after 1 mg/day, the dose will be increased by 1 mg/day to the maximum 6 mg/day. |
| Name | Type | Description |
|---|---|---|
| ropinirole controlled release (CR)-RLS | DRUG | White film-coated round-shaped tablet |
Inclusion Criteria: * A subject will be considered eligible for inclusion in this study only if all of the following criteria apply: At Week -1 (at the start of Screening period) * Patients who are diagnosed with RLS according to the International RLS Study Group's (IRLSSG) Diagnostic Criteria. *...
Ropinirole controlled release-RLS is an investigational small molecule being studied for Restless Legs Syndrome and Parkinson's Disease. It is a controlled-release formulation of ropinirole, a dopamine agonist. The drug is in clinical development for these neurological conditions, though it is not yet approved.
Ropinirole controlled release-RLS is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Restless Legs Syndrome and Parkinson's Disease.
Ropinirole controlled release-RLS is in Phase 2 clinical development for Restless Legs Syndrome. A Phase 3 trial was also completed for Parkinson's Disease. The drug remains investigational and has not been approved by regulatory authorities.
Ropinirole controlled release-RLS has been evaluated in two completed trials. NCT00363727 was a Phase 3 study in Parkinson's Disease with 209 participants, and NCT00530790 was a Phase 2 study in Restless Legs Syndrome with 35 participants. Both trials are completed.
Yes, ropinirole controlled release-RLS is also known as REQUIP CR, as referenced in the clinical trial NCT00363727. This controlled-release formulation of ropinirole is being studied for Restless Legs Syndrome and Parkinson's Disease.