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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 Down titration phase Subjects who complete Week 54 or withdrawn will be down titrated over a 1 to 4 weeks period.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...
Ropinirole PR is an investigational small molecule being studied as adjunctive therapy to L-dopa in patients with advanced Parkinson's Disease. It is a prolonged release formulation of ropinirole, a dopamine agonist, intended to be added to L-dopa treatment to help manage symptoms in this patient population.
Ropinirole PR targets dopamine receptors. As a dopamine agonist, it works by stimulating dopamine receptors in the brain, which helps compensate for the loss of dopamine-producing neurons in Parkinson's Disease. This mechanism is intended to improve motor symptoms when used alongside L-dopa therapy.
Ropinirole PR 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 safety and efficacy of this prolonged release formulation for the treatment of advanced Parkinson's Disease.
Ropinirole PR is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform whether the drug can proceed to regulatory submission for approval.
Ropinirole PR has one completed Phase 3 clinical trial registered as NCT00823836. This trial evaluated the drug as adjunctive therapy to L-dopa in 302 patients with advanced Parkinson's Disease in Japan. The study was randomized, double-blind, and active-controlled, and enrolled adults aged 20 years and older.
Ropinirole PR is a prolonged release formulation of ropinirole, an established dopamine agonist. The PR designation indicates that the drug is designed to release the active ingredient slowly over time, potentially allowing for less frequent dosing compared to immediate-release ropinirole. It is being studied specifically for adjunctive use with L-dopa in advanced Parkinson's Disease.