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Ropinirole

Phase 3

Parkinson Disease | Small molecule | Neurology |GSK plc|Last Updated: Jun 19, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment445

FDA Designations

No designations recorded

Clinical trial landscape

Ropinirole · 8 trials · 4 indications

Phase 3 5Phase 2 2Phase 1 1
NCT00314860RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of RopiniroleRestless Legs Syndrome
COMPLETED568 Analytics
NCT00355641Long-Term Safety Of Ropinirole XR In Patients With Restless Legs SyndromeRestless Legs Syndrome
COMPLETED450 Analytics
NCT00197080Ropinirole XR (Extended Release) In Patients With Restless Legs SyndromeRestless Legs Syndrome
COMPLETED380 Analytics
NCT00363857A Clinical Research Study Testing Ropinirole Treatment for Restless Legs SyndromeRestless Legs Syndrome (RLS)
COMPLETED360 Analytics
NCT00381472Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopaParkinson Disease
COMPLETED393 Analytics
PHASE3COMPLETED
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
Restless Legs Syndrome
NCT00314860568
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PHASE3COMPLETED
Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome
Restless Legs Syndrome
NCT00355641450
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PHASE3COMPLETED
Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome
Restless Legs Syndrome
NCT00197080380
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PHASE3COMPLETED
A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome
Restless Legs Syndrome (RLS)
NCT00363857360
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PHASE3COMPLETED
Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopa
Parkinson Disease
NCT00381472393
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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
Improvement in RLS severity rating scale at Week 12
Mean change from baseline in awake time "off" at Week 24 LOCF (last observation carried forward).
Ropinirole AUC, the area under the plasma concentration-time curve over 24 hours Ropinirole maximum plasma concentration over 24 hours
24 hours
Change in pain intensity score from baseline to last week of treatment (week 12)
Profile of Pharmacokinetics
predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24,36,48,72, 96,120,144,168 hours post-dose

Cmax, AUC (0-24), AUC(0-inf)

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
Subjects receiving ropiniroleEXPERIMENTALEligible subjects will receive single and multiple oral dose of ropinirole prolonged release tablet in sequence over 14 days without dosing on washout period from Day 2 to Day 7.

Interventions

NameTypeDescription
ropinirole Extended Release (XR)DRUG -
RopiniroleDRUG -
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Eligibility Criteria

Age Range18 Years to 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 KingdomCanadaCzechiaHungaryPolandSouth AfricaFinlandChina
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Competitive Landscape -Parkinson's Disease 58 trials (matched to "Parkinson Disease")

CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN2PHASE3apomorphine infusion
Prothena Corp. PlcPRTA3PHASE3Prasinezumab
Biohaven Ltd.BHVN1PHASE2BHV-8000
Denali Therapeutics Inc.DNLI1PHASE2BIIB122
AC Immune SAACIU2PHASE2ACI-7104.056 at Dose A, ACI-7104.056 at Dose B, ACI-7104.056 at Dose C
Gain Therapeutics, Inc.GANX2PHASE2Low Dose GT-02287
Eli Lilly and CompanyLLY3PHASE1LY3884961, Methylprednisolone, Sirolimus
Annovis Bio IncANVS1PHASE2buntanetap/posiphen
Regeneron Pharmaceuticals, Inc.REGN2PHASE1ALN-SNCA
QIAGEN NVQGEN1PHASE2NEU-411
AbbVie, Inc.ABBV9 - Undisclosed
Illumina, Inc.ILMN1PHASE218F-MFBG
MeiraGTx Holdings PlcMGTX1PHASE1AAV-GAD
Masimo CorporationMASI1PHASE1Diprivan, Astra-Zeneca
Boston Scientific CorporationBSX3 - Undisclosed
AgeX Therapeutics, Inc.SER1PHASE1SER-252
Abbott LaboratoriesABT2N/AUndisclosed
Ardelyx, Inc.ARDX1PHASE2Tenapanor
Novo Nordisk A/S Sponsored ADR Class BNVO1 - Undisclosed
Sage BionetworksSAGE1N/AUndisclosed
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Frequently asked questions about Ropinirole

What is Ropinirole used for?

Ropinirole is a small molecule being studied for Parkinson Disease, Restless Legs Syndrome (RLS), and Fibromyalgia Syndrome, Primary. It is developed by GSK plc and is in clinical development for these neurological conditions.

What does Ropinirole target?

Ropinirole is a small molecule developed for neurological conditions. Its specific molecular target is not disclosed in the available information, so its mechanism of action is not detailed here.

Who makes Ropinirole?

Ropinirole is 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 for various neurological indications.

What phase is Ropinirole in?

Ropinirole is in Phase 3 clinical development. It has completed trials in Phase 1, Phase 2, and Phase 3, but it remains investigational and is not yet approved for any use.

What clinical trials is Ropinirole in?

Ropinirole has completed three clinical trials. NCT00363857 tested it for Restless Legs Syndrome in Phase 3, NCT00256893 tested it for Fibromyalgia Syndrome, Primary in Phase 2, and NCT00460148 studied its absorption, distribution, metabolism, and excretion in Parkinson Disease patients.

Is Ropinirole the same as Requip?

Ropinirole is also known by the brand name Requip. This alternative name is used in clinical and commercial contexts, and patients or healthcare providers may refer to the drug by either name.