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Ropinirole prolonged release

Phase 3

Parkinson Disease | Small molecule | Neurology |GSK plc|Last Updated: Aug 22, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment343

FDA Designations

No designations recorded

Clinical trial landscape

Ropinirole prolonged release · 1 trial · 1 indication

Phase 3 1
NCT00331149A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson'sParkinson Disease
COMPLETED343 Analytics
PHASE3COMPLETED
A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's
Parkinson DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants with at least a 20% maintained reduction in Baseline time spent "off" at Week 24 last observation carried forward (LOCF)
Baseline (Week 0) and Week 24

Diary cards completed by the participants was used to assess the duration of "off" and "on" periods. During the treatment period 2, 24 hour diary cards were completed by the participants (except for the Baseline period when four diary cards were completed). The participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Percentage of participants with at least a 20% maintained reduction in baseline time spent "off" at Week 24 were presented.

Secondary Endpoints

Mean change from Baseline in percentage awake time spent "off" at Week 24 LOCF
Baseline (Week 0) and Week 24
Number of participants with a score of 'much improved' or 'very much improved' on the clinical global impression-global improvement (CGI-I) scale at Week 24 LOCF
Week 24
Mean change from baseline in the total motor score (part III) of the Unified Parkinson's Disease Rating Scale (UPDRS), with participants in an "on" state at Week 24 LOCF
Baseline (Week 0) and Week 24
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Study Design & Arms

AllocationRANDOMIZED
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Ropinirole prolonged releaseDRUG -
ropinirole immediate releaseDRUG -
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Eligibility Criteria

Age Range30 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites81

Inclusion criteria: * Patients with a diagnosis of advanced idiopathic Parkinson's disease (according to modified Hoehn \& Yahr criteria Stages II-IV) whose symptoms are not adequately controlled with L-dopa. Exclusion criteria: * Patients with late stage advanced Parkinson's disease with incapac...

Countries:BulgariaCanadaCzechiaFranceGermanyHungaryItalyPolandRomaniaRussiaSouth AfricaSpainUkraineUnited Kingdom
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Frequently asked questions about Ropinirole prolonged release

What is Ropinirole prolonged release used for?

Ropinirole prolonged release is used for Parkinson Disease. It is a small molecule being developed by GSK plc (GSK) for this neurological condition. The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved for use.

What does Ropinirole prolonged release target?

Ropinirole prolonged release is a small molecule developed for Parkinson Disease. The specific molecular target has not been disclosed in the available information, so its mechanism of action is not described here.

Who makes Ropinirole prolonged release?

Ropinirole prolonged release is developed by GSK plc, a pharmaceutical company traded under the ticker GSK. The drug is being studied for the treatment of Parkinson Disease and is currently in Phase 3 clinical trials.

What phase is Ropinirole prolonged release in?

Ropinirole prolonged release is in Phase 3 clinical development for Parkinson Disease. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 343 patients.

What clinical trials is Ropinirole prolonged release in?

Ropinirole prolonged release has one completed Phase 3 trial, NCT00331149, titled 'A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's'. The trial enrolled 343 patients across multiple countries including Bulgaria, Canada, Czechia, France, Germany, Hungary, Italy, Poland, Romania, Russia, South Africa, Spain, Ukraine, and the United Kingdom.

Is Ropinirole prolonged release the same as Ropinirole immediate release?

Ropinirole prolonged release is a distinct formulation from Ropinirole immediate release. The completed clinical trial NCT00331149 directly compared the two formulations in patients with advanced Parkinson's Disease, indicating they are separate versions of the same active ingredient with different release profiles.