Recent Updates
Recently added Catalysts

Ropinirole Immediate Release

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

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 Syndrome
NCT001407129
Unlock 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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

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. It is currently in Phase 1 clinical development as an investigational drug. The drug is being evaluated in young patients with this condition, though it is not yet approved for any use.

Who makes Ropinirole Immediate Release?

Ropinirole Immediate Release is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Restless Legs Syndrome.

What phase is Ropinirole Immediate Release in?

Ropinirole Immediate Release is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Restless Legs Syndrome, with one completed Phase 1 trial involving 9 participants.

What clinical trials is Ropinirole Immediate Release in?

Ropinirole Immediate Release has one completed clinical trial registered as NCT00140712, titled 'Ropinirole Tablets In Young Patients With Restless Legs Syndrome'. This Phase 1 study enrolled 9 participants aged 12 years and older in the United States, Belgium, and France. The trial was uncontrolled and not randomized.

How does Ropinirole Immediate Release work?

Ropinirole Immediate Release is a small molecule drug being investigated for Restless Legs Syndrome. As a small molecule, it is designed to interact with biological targets in the body, though the specific molecular target for this drug has not been disclosed in the available clinical trial information.