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Ropinirole prolonged release

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment343
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00331149A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson'sPHASE3 COMPLETED 343Jun 20, 2006Aug 29, 2007Aug 22, 201781 Bulgaria, Canada +12
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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 — 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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