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ropinirole dosing for up to 28 days

Phase 1

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

ropinirole dosing for up to 28 days development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2007

ropinirole dosing for up to 28 days target and mechanism

Molecular targetDRD2, DRD3, DRD4
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL589

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

ropinirole dosing for up to 28 days clinical trials

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 used for?

Ropinirole is a small molecule drug developed by GSK plc for Restless Legs Syndrome, a neurological condition. It has been studied in a Phase 1 clinical trial in patients with end stage renal disease undergoing hemodialysis. The trial, NCT00422994, completed with 48 participants.

What does ropinirole target?

Ropinirole targets the dopamine receptors DRD2, DRD3, and DRD4, acting as an agonist. This means it stimulates these receptors, which are involved in neurological signaling. The drug is being developed for Restless Legs Syndrome, a condition where dopamine dysfunction is implicated.

Who is developing ropinirole?

Ropinirole is being developed by GSK plc, a pharmaceutical company traded under the ticker GSK. GSK is responsible for the clinical development of this small molecule drug for Restless Legs Syndrome.

What phase is ropinirole in?

Ropinirole is in Phase 1 clinical development. A Phase 1 trial, NCT00422994, has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is ropinirole in?

Ropinirole has been studied in one 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 was completed, enrolled 48 participants, and took place in the United States and United Kingdom.