Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ropinirole PR · 1 trial · 1 indication
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants who withdrew before Week 2 and who had only one observation for the part III total score were not included in the analysis.
| Arm | Type | Description |
|---|---|---|
| ropinirolePR-PR group | EXPERIMENTAL | - |
| ropiniroleIR-PR group | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ropinirole PR/XR | DRUG | Double-blind non-inferiority verification phase (24 weeks) At the baseline visit (Week 0), subjects who completed screening period will be randomised (1:1) to double-blind treatment with either ropinirole PR-PR group or ropinirole IR-PR group. The subjects'dose will be titrated according to the recommended schedule to achieve an optimal therapeutic response (ropinirolePR/XR2-15 mg/day ,ropinirolIR0.75-15 mg/day). Double-blind PR/XR switching phase (8 weeks) Ropinirole IR-PR subjects will be switched overnight to a similar dose of ropinirole PR/XR, while the remaining ropinirole PR-PR group will continue on the same dosage. Double blind long-term treatment phase (22 weeks) The same dose level at the end of PR/XR switching phase will be continued till week 54 under blind. Down titration phase Subjects who complete Week 54 or withdrawn will be down titrated over a 1 to 4 weeks period. |
| ropinirole IR | DRUG | Double-blind non-inferiority verification phase (24 weeks) At the baseline visit (Week 0), subjects who completed screening period will be randomised (1:1) to double-blind treatment with either ropinirole PR-PR group or ropinirole IR-PR group. The subjects'dose will be titrated according to the recommended schedule to achieve an optimal therapeutic response (ropinirolePR/XR2-15 mg/day ,ropinirolIR0.75-15 mg/day). Double-blind PR/XR switching phase (8 weeks) Ropinirole IR-PR subjects will be switched overnight to a similar dose of ropinirole PR/XR, while the remaining ropinirole PR-PR group will continue on the same dosage. Double blind long-term treatment phase (22 weeks) The same dose level at the end of PR/XR switching phase will be continued till week 54 under blind. Down titration phase Subjects who complete Week 54 or withdrawn will be down titrated over a 1 to 4 weeks period. |
Inclusion Criteria: Inclusion criteria at the start of the screening * Patients who are diagnosed with advanced Parkinson's disease (PD) with severity of the modified Hoehn \& Yahr criteria Stages II-IV. * Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to screening phase and...
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Ropinirole PR is a prolonged release formulation of ropinirole used to treat Parkinson disease. It is studied as adjunctive therapy alongside L-dopa in patients with advanced Parkinson disease. The prolonged release tablet is designed to provide extended drug exposure compared with immediate release ropinirole.
Ropinirole PR targets the dopamine receptors DRD2, DRD3, and DRD4, acting as an agonist at these receptors. By stimulating dopamine receptors, it is intended to compensate for reduced dopaminergic signaling in Parkinson disease. This receptor agonist activity underlies its use as an adjunct to L-dopa therapy.
Ropinirole PR is developed by GSK plc, which trades under the ticker GSK. GSK is the company associated with the development of this prolonged release formulation of ropinirole for Parkinson disease.
Ropinirole PR is in Phase 3 clinical development. It is an investigational prolonged release formulation and is not described as approved. The Phase 3 program has been conducted in Parkinson disease, with one completed trial listed.
Ropinirole PR has been studied in the Phase 3 trial NCT00823836, titled Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease. The trial was completed, enrolled 302 participants, was randomized, double blind, and active controlled, and was conducted in Japan.