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ropinirole dosing for up to 28 days

Phase 1

Restless Legs Syndrome | Small molecule | Other |GSK plc|Last Updated: Oct 26, 2016

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
UNCONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00422994A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of RopinirolePHASE1 COMPLETED 48Apr 1, 2006Dec 1, 2006Oct 26, 20162 United States, United Kingdom
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Study Endpoints
Primary Endpoints
SK&F-104557 and SK&F-89124 blood levels over 24 hours at Weeks 1 & 3 for all subjects.
SK&F-104557 and SK&F-89124 blood levels at beginning, middle, & end of hemodialysis period when "on dialysis" & "off dialysis" in patients.
Secondary Endpoints
ECG: every other visit
Vital Signs: Each visit
Adverse Events: each visit
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
ropinirole dosing for up to 28 daysDRUG -
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Eligibility Criteria
Age Range18 Years — 79 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion: * Patients and subjects between 18-79 years old. * End stage renal patients who are consistently receiving dialysis for a minimum of 3.5 hours, three times per week, with hemodialysis blood flow rates of \>200mL/min may be eligible to enter the study. * Patients must also have systolic b...

Countries:United StatesUnited Kingdom
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