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Ropinirole Immediate Release

Phase 1

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

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00140712Ropinirole Tablets In Young Patients With Restless Legs SyndromePHASE1 COMPLETED 9 — — Jun 10, 2005Feb 28, 2008Sep 11, 20179 United States, Belgium +1
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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 — 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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