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ropinirole dosing for up to 28 days

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

ropinirole dosing for up to 28 days · 1 trial · 1 indication

Phase 1 1
NCT00422994A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of RopiniroleRestless Legs Syndrome
COMPLETED48 Analytics
PHASE1COMPLETED
A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole
Restless Legs SyndromeUnlock trial analytics

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 to 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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Frequently asked questions about ropinirole dosing for up to 28 days

What is ropinirole dosing for up to 28 days used for?

Ropinirole dosing for up to 28 days is used for Restless Legs Syndrome, a neurological condition. It is a small molecule being studied in a Phase 1 clinical trial to investigate the effects of end stage renal disease and hemodialysis on the pharmacokinetics of ropinirole.

Who makes ropinirole dosing for up to 28 days?

Ropinirole dosing for up to 28 days is developed by GSK plc, which trades under the ticker GSK. The company is conducting a Phase 1 clinical trial for this small molecule intended for Restless Legs Syndrome.

What phase is ropinirole dosing for up to 28 days in?

Ropinirole dosing for up to 28 days is in Phase 1 clinical development. It is an investigational drug for Restless Legs Syndrome, and the single clinical trial listed for it has been completed. It is not approved by the FDA.

What clinical trials is ropinirole dosing for up to 28 days in?

Ropinirole dosing for up to 28 days has one completed clinical trial, NCT00422994, titled 'A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole'. This Phase 1 trial enrolled 48 participants with Restless Legs Syndrome in the United States and United Kingdom.

Is ropinirole dosing for up to 28 days the same as ropinirole?

Ropinirole dosing for up to 28 days is a formulation or dosing regimen of ropinirole, a small molecule used for Restless Legs Syndrome. The clinical trial NCT00422994 investigates the pharmacokinetics of ropinirole in patients with end stage renal disease undergoing hemodialysis.