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Ropinirole

Phase 3

Restless Legs Syndrome | Small molecule | Other |GSK plc|Last Updated: Oct 28, 2016

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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment1,398
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00314860RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of RopinirolePHASE3 COMPLETED 568 — — Feb 1, 2006Dec 1, 2006Oct 18, 201691 United States, Australia +11
NCT00355641Long-Term Safety Of Ropinirole XR In Patients With Restless Legs SyndromePHASE3 COMPLETED 450 — — Oct 1, 2005Oct 1, 2007Oct 28, 201665 United States, Canada
NCT00197080Ropinirole XR (Extended Release) In Patients With Restless Legs SyndromePHASE3 COMPLETED 380 — — Jun 1, 2005Jan 1, 2006Sep 23, 201670 United States, Canada
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Study Endpoints
Primary Endpoints
To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms
12 Weeks
Incidence/severity of adverse events Changes in vital signs Labs ECG Assessment of augmentation and rebound (worsening of RLS symptoms).
Up to 52 Weeks
The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.
12 Weeks
Secondary Endpoints
To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS.
12 Weeks
Change from baseline in IRLS Rating Scale total score CGI Scale scores Medical Outcomes Study Sleep Scale scores Other subject-reported health outcomes.
Up to 52 Weeks
Incidence and severity of adverse events.
Up to 52 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open LabelEXPERIMENTALAll subjects will receive ropinirole XR in this study. The total daily dose range of ropinirole XR will be 0.5mg to 6.0mg daily
Interventions
NameTypeDescription
ropinirole Extended Release (XR)DRUG -
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Eligibility Criteria
Age Range18 Years — 79 Years
SexALL
Healthy VolunteersNo
Study Sites91

Inclusion Criteria: * Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria. * Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring ...

Countries:United StatesAustraliaAustriaBelgiumDenmarkFranceGermanyItalyNetherlandsNorwaySpainSwedenUnited KingdomCanada
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