Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Requip PR · 2 trials · 1 indication
AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.
An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase.
AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.
An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.
An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.
The "off" state is defined as the state in which Parkinson's Disease (PD) symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods in 24-hour diary cards prior to each visit on two days of each relevant week. The total number of awake hours spent "off" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.
| Arm | Type | Description |
|---|---|---|
| Requip PR | EXPERIMENTAL | Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| Requip PR | DRUG | Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control. |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Subjects must have completed 24 weeks of randomised treatment in study ROP111528(and must have completed the one-week downtitration at the end of treatment/early withdrawal). 2. Subjects must not have a break in medication between completing the downtitration phase for studie...
Requip PR is used for Parkinson Disease. It is a small molecule being developed by GSK plc as an adjunctive therapy for patients with Parkinson's disease who are not optimally controlled on L-dopa. The drug is currently in Phase 3 clinical development.
Requip PR is a small molecule developed for Parkinson Disease. Its specific molecular target is not disclosed in the available clinical trial information. The drug is being studied as an adjunctive therapy to L-dopa in patients with Parkinson's disease.
Requip PR is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is being investigated for the treatment of Parkinson Disease and is currently in Phase 3 clinical trials.
Requip PR is in Phase 3 clinical development. Two Phase 3 trials have been completed, both in China, with a total enrollment of 642 participants. The drug is investigational and has not been reported as approved by regulatory authorities.
Requip PR has been studied in two completed Phase 3 trials. NCT01154166 was a randomized, double-blind, placebo-controlled study of six months treatment with ropinirole PR as adjunctive therapy in Parkinson's disease patients not optimally controlled on L-dopa, enrolling 347 participants. NCT01536574 was an open-label extension study enrolling 295 participants.
Requip PR is also known as ropinirole PR. The clinical trial NCT01154166 refers to the drug as ropinirole PR, and the extension study NCT01536574 is titled with REQUIP PR. Both names refer to the same drug being developed for Parkinson Disease.