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ropinirole controlled-release for RLS

Phase 3

Parkinson's Disease | Small molecule | Neurology |GSK plc|Last Updated: Jan 18, 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment209
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00363727Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson'sPHASE3 COMPLETED 209Dec 1, 2003Jan 1, 2006Jan 18, 201769 United States
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Study Endpoints
Primary Endpoints
Number of participants with time to onset of dyskinesia of treatment over 104 weeks (2 years)
Up to 2 Years

Median time to dyskinesia could not be estimated by Kaplan-Meier methods because of the small number of events; however, number of participants with dyskinesia requiring days from the date of randomization (Day 1) to the date at which a participant has the event of interest were reported

Secondary Endpoints
Change from Baseline (Day 1) in united PD rating scale (UPDRS) activities of daily living (ADL) score (Part II) at Week 28 and 104
At Weeks 28 and 104
Change from Baseline (Day 1) UPDRS motor score (UPDRS Part III) over period at Week 28 and Week 104
Baseline (Day 1), Week 28, and Week 104
Number of participants with symptoms of dyskinesia over period
Upto week 106
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
ropinirole controlled-release (REQUIP CR) for RLSDRUG -
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Eligibility Criteria
Age Range30 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites69

Inclusion Criteria: * Must be on 600mg or less of levodopa therapy for two years or less. * Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening. Exclusion Criteria: * Current or past history of Dyskinesia. * State of dementia or have a MMSE score \< 26 at screenin...

Countries:United States
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