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Also known as ropinirole controlled release (CR)-RLS, ropinirole controlled-release (REQUIP CR) for RLS, ropinirole controlled-release for RLS
ropinirole controlled release-RLS · 2 trials · 4 indications
Median time to dyskinesia could not be estimated by Kaplan-Meier methods because of the small number of events; however, number of participants with dyskinesia requiring days from the date of randomization (Day 1) to the date at which a participant has the event of interest were reported
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 (REQUIP CR) for RLS | DRUG | - |
| ropinirole controlled release (CR)-RLS | DRUG | White film-coated round-shaped tablet |
Inclusion Criteria: * Must be on 600mg or less of levodopa therapy for two years or less. * Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening. Exclusion Criteria: * Current or past history of Dyskinesia. * State of dementia or have a MMSE score \< 26 at screenin...
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Ropinirole controlled release-RLS is a small molecule therapy being developed for Restless Legs Syndrome and Parkinson's Disease. It is a controlled-release formulation designed to provide once-daily dosing. The drug is in Phase 3 development and is being advanced by GSK plc.
Ropinirole controlled release-RLS targets the dopamine receptors DRD2, DRD3, and DRD4 as an agonist. By activating these receptors, it mimics the action of dopamine in the brain, which is relevant to both Restless Legs Syndrome and Parkinson's Disease.
Ropinirole controlled release-RLS is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this controlled-release formulation for Restless Legs Syndrome and Parkinson's Disease.
Ropinirole controlled release-RLS is in Phase 3 development. It is an investigational therapy and has not been approved by the FDA. The program includes completed trials in both Restless Legs Syndrome and Parkinson's Disease.
Ropinirole controlled release-RLS has been studied in two completed trials. NCT00530790 was a Phase 2 trial in Restless Legs Syndrome conducted in Japan with 35 participants. NCT00363727 was a Phase 3 trial in Parkinson's Disease in the United States with 209 participants.
Yes, ropinirole controlled release-RLS is also known as ropinirole controlled-release (REQUIP CR) for RLS and ropinirole controlled-release for RLS. These names refer to the same controlled-release formulation of ropinirole developed by GSK for Restless Legs Syndrome and Parkinson's Disease.