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Ropinirole Immediate Release

Phase 3

Restless Legs Syndrome | Small molecule | Neurology |GSK plc|Trials Updated: Sep 11, 2017

Ropinirole Immediate Release development status

Highest phase Phase 3 (NCT00331149)
Phase scored for GSKPhase 1
Registered trials 2 across 1 sponsor since Sep 2005

Ropinirole Immediate Release 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 Enrollment9

FDA Designations

No designations recorded

Ropinirole Immediate Release clinical trials

Ropinirole Immediate Release · 1 trial · 1 indication

Phase 1 1
NCT00140712Ropinirole Tablets In Young Patients With Restless Legs SyndromeRestless Legs Syndrome
COMPLETED9 Analytics
PHASE1COMPLETED
Ropinirole Tablets In Young Patients With Restless Legs Syndrome
Restless Legs SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

AUC(0-8), Cmax. Safety (adverse events, vital signs, ECG, laboratory parameters), Change in BP, Incidence of adverse events. Number of periodic limb movements and Number of periodic limb movements per hour (as measured by actigraphy).
Up to 3 years

Secondary Endpoints

PK - tmax, t1/2, For SKF-89124 and SKF-104557 - ratio of metabolite AUC:ropinirole AUC. PD - Leg movement as measured by actigraphy.
Up to 3 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RopiniroleEXPERIMENTALsingle dose .25mg of IR formulation, .05mg of RLS controlled release

Interventions

NameTypeDescription
Ropinirole Immediate ReleaseDRUGRopinirole Immediate Release
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Eligibility Criteria

Age Range12 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Adolescent subjects diagnosed with probable or definite Restless Leg Syndrome (RLS). Exclusion Criteria: * Subjects who require RLS treatment during the daytime, suffer from other primary sleep disorders or are taking medication known to induce drowsiness, affect RLS or slee...

Countries:United StatesBelgiumFrance
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Frequently asked questions about Ropinirole Immediate Release

What is Ropinirole Immediate Release used for?

Ropinirole Immediate Release is a small molecule being studied for Restless Legs Syndrome, a neurological condition that causes an urge to move the legs. The Phase 1 trial NCT00140712 evaluated ropinirole tablets in young patients with Restless Legs Syndrome across the United States, Belgium, and France.

What does Ropinirole Immediate Release target?

Ropinirole Immediate Release targets the dopamine receptors DRD2, DRD3, and DRD4, where it acts as an agonist. By activating these receptors, the drug is designed to influence dopamine signaling relevant to Restless Legs Syndrome. This receptor agonist activity is the basis for its development in Neurology.

Who makes Ropinirole Immediate Release?

Ropinirole Immediate Release is developed by GSK plc, which trades under the ticker GSK. The company is the sponsor behind the clinical development of this small molecule for Restless Legs Syndrome.

What phase is Ropinirole Immediate Release in?

Ropinirole Immediate Release is in Phase 1 development. It is investigational and has not been approved by the FDA. One Phase 1 trial, NCT00140712, has been completed, and no trials are currently active.

What clinical trials is Ropinirole Immediate Release in?

Ropinirole Immediate Release has been studied in one completed Phase 1 trial, NCT00140712, titled Ropinirole Tablets In Young Patients With Restless Legs Syndrome. The trial enrolled 9 patients aged 12 years and older in the United States, Belgium, and France. It was an uncontrolled study without randomization or double blinding.