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ropinirole controlled-release for RLS

Phase 3

Parkinson's Disease | Small molecule | Neurology |GSK plc|Last Updated: Jan 18, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment209

FDA Designations

No designations recorded

Clinical trial landscape

ropinirole controlled-release for RLS · 1 trial · 3 indications

Phase 3 1
NCT00363727Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson'sParkinson's Disease
COMPLETED209 Analytics
PHASE3COMPLETED
Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's
Parkinson's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with time to onset of dyskinesia of treatment over 104 weeks (2 years)
Up to 2 Years

Median time to dyskinesia could not be estimated by Kaplan-Meier methods because of the small number of events; however, number of participants with dyskinesia requiring days from the date of randomization (Day 1) to the date at which a participant has the event of interest were reported

Secondary Endpoints

Change from Baseline (Day 1) in united PD rating scale (UPDRS) activities of daily living (ADL) score (Part II) at Week 28 and 104
At Weeks 28 and 104
Change from Baseline (Day 1) UPDRS motor score (UPDRS Part III) over period at Week 28 and Week 104
Baseline (Day 1), Week 28, and Week 104
Number of participants with symptoms of dyskinesia over period
Upto week 106
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ropinirole controlled-release (REQUIP CR) for RLSDRUG -
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Eligibility Criteria

Age Range30 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites69

Inclusion Criteria: * Must be on 600mg or less of levodopa therapy for two years or less. * Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening. Exclusion Criteria: * Current or past history of Dyskinesia. * State of dementia or have a MMSE score \< 26 at screenin...

Countries:United States
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Frequently asked questions about ropinirole controlled-release for RLS

What is ropinirole controlled release-RLS used for?

Ropinirole controlled release-RLS is an investigational small molecule being studied for Restless Legs Syndrome and Parkinson's Disease. It is a controlled-release formulation of ropinirole, a dopamine agonist. The drug is in clinical development for these neurological conditions, though it is not yet approved.

Who makes ropinirole controlled release-RLS?

Ropinirole controlled release-RLS is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Restless Legs Syndrome and Parkinson's Disease.

What phase is ropinirole controlled release-RLS in?

Ropinirole controlled release-RLS is in Phase 2 clinical development for Restless Legs Syndrome. A Phase 3 trial was also completed for Parkinson's Disease. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is ropinirole controlled release-RLS in?

Ropinirole controlled release-RLS has been evaluated in two completed trials. NCT00363727 was a Phase 3 study in Parkinson's Disease with 209 participants, and NCT00530790 was a Phase 2 study in Restless Legs Syndrome with 35 participants. Both trials are completed.

Is ropinirole controlled release-RLS the same as REQUIP CR?

Yes, ropinirole controlled release-RLS is also known as REQUIP CR, as referenced in the clinical trial NCT00363727. This controlled-release formulation of ropinirole is being studied for Restless Legs Syndrome and Parkinson's Disease.