Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ropinirole IR · 1 trial · 2 indications
AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 1 period and during the post-conversion 1 period. The second conversion population consisted of all participants receiving at least one dose of randomized drug during the pre-conversion 2 period and during the post-conversion 2 period.
| Arm | Type | Description |
|---|---|---|
| Ropinirole cohort A1: 1 mg IR/2 mg CR-RLS/1 mg IR/1 mg IR | EXPERIMENTAL | Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 1 mg IR at bedtime and continued to receive the same till the end of Week 4. |
| Ropinirole cohort A2: 1 mg IR/1 mg IR/1 mg IR/2 mg CR-RLS | EXPERIMENTAL | Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 2 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4. |
| Ropinirole cohort B1: 2 mg IR/3 mg CR-RLS/2 mg IR/2 mg IR | EXPERIMENTAL | Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 2 mg IR at bedtime and continued to receive the same till the end of Week 4. |
| Ropinirole cohort B2: 2 mg IR/2 mg IR/2 mg IR/3 mg CR-RLS | EXPERIMENTAL | Participants received Placebo in the evening and Ropinirole 2 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 3 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4. |
| Ropinirole cohort C1: 4 mg IR/6 mg CR-RLS/4 mg IR/4 mg IR | EXPERIMENTAL | Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, participants were converted back to receive placebo in the evening and Ropinirole 4 mg IR at bedtime and continued to receive the same till the end of Week 4. |
| Ropinirole cohort C2: 4 mg IR/4 mg IR/4 mg IR/6 mg CR-RLS | EXPERIMENTAL | Participants received Placebo in the evening and Ropinirole 4 mg IR at bedtime on Week 1 and continued to receive the same till the end of Week 3. At the end of Week 3, participants were switched to receive Ropinirole 6 mg CR-RLS in the evening and placebo at bedtime till the end of Week 4. |
| Name | Type | Description |
|---|---|---|
| Ropinirole IR 1 mg | DRUG | Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance. |
| Ropinirole IR 2 mg | DRUG | Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2.0mg of active drug substance. |
| Ropinirole IR 1 mg Placebo | DRUG | Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 1 mg. |
| Ropinirole IR 2 mg Placebo | DRUG | Ropinirole IR (SKF-101468) placebo will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg. |
| Ropinirole CR 2 mg | DRUG | Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 2mg of the active drug substance. |
| Ropinirole CR 3 mg | DRUG | Ropinirole CR Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 3mg of the active drug substance. |
| Ropinirole CR 2 mg Placebo | DRUG | Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 2 mg. |
| Ropinirole CR 3 mg Placebo | DRUG | Ropinirole CR placebo Tablets are presented as 7 mm round, bi-convex, white film coated tablets, de-bossed with 'GS' on both faces, containing matching placebo tablets of 3 mg. |
Inclusion Criteria: * Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria. * Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily. * Subjects with RLS symptoms during both the evening and night or night time only. * Su...
Ropinirole IR is used for Restless Legs Syndrome (RLS). It is an immediate-release small molecule being developed by GSK plc for this neurological condition. The drug is currently in Phase 3 clinical development, meaning it is still investigational and has not yet been approved for use.
Ropinirole IR is a small molecule that acts as a dopamine agonist, targeting dopamine receptors in the brain. By stimulating these receptors, it helps to alleviate the symptoms of Restless Legs Syndrome. This mechanism is central to its therapeutic effect in treating the condition.
Ropinirole IR is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of Restless Legs Syndrome.
Ropinirole IR is in Phase 3 clinical development. This is the final stage of testing before a potential regulatory submission. The drug is still investigational and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 135 participants.
Ropinirole IR has one completed Phase 3 clinical trial registered under NCT00256854. The trial, titled 'Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS', enrolled 135 participants in the United States. The study was controlled but not double-blind, and it included adults aged 18 years and older.
Ropinirole IR is the immediate-release formulation of ropinirole, which is different from the controlled-release version. The clinical trial NCT00256854 specifically studied converting patients from the immediate-release to the controlled-release formulation for Restless Legs Syndrome, indicating they are distinct formulations of the same active ingredient.