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Ropinirole

Generic Name
Ropinirole
Brand Names
Requip
Drug Type
Small Molecule
Chemical Formula
C16H24N2O
CAS Number
91374-21-9
Unique Ingredient Identifier
030PYR8953
Background

Ropinirole, also known as ReQuip, is a non-ergoline dopamine agonist used in Parkinson's disease and restless legs syndrome , . It is manufactured by GlaxoSmithKline Pharmaceuticals. Ropinirole was initially approved in 1997 by the FDA for the management of Parkinson's disease. In 2005, it was the first drug approved in the US for the management of primary moderate to severe restless legs syndrome .

In 2008, the extended-release capsules of ropinirole were approved, allowing for less frequent dosing, therefore increased compliance, and offering a similar side effect profile and efficacy to previous formulations of ropinirole .

Indication

For the treatment of the signs and symptoms of Parkinson's disease and for the treatment of primary moderate-severe restless legs syndrome .

Associated Conditions
Idiopathic Parkinson's Disease, Moderate restless legs syndrome (RLS), Parkinson's Disease (PD), Severe restless legs syndrome (RLS)

The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-01-27
Last Posted Date
2009-09-15
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
46
Registration Number
NCT00830219
Locations
🇺🇸

Novum Pharmaceutical Research Services, Houston, Texas, United States

Ropinirole 0.25 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-01-27
Last Posted Date
2009-09-11
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
44
Registration Number
NCT00829504
Locations
🇺🇸

Novum Pharmaceutical Research Services, Houston, Texas, United States

Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease

Phase 3
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2009-01-16
Last Posted Date
2017-01-18
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
302
Registration Number
NCT00823836
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions

Not Applicable
Completed
Conditions
Parkinson's Disease
Restless Leg Syndrome
First Posted Date
2008-05-07
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
30
Registration Number
NCT00673088

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions

Not Applicable
Completed
Conditions
Restless Leg Syndrome
Parkinson's Disease
First Posted Date
2008-05-07
Last Posted Date
2018-01-23
Lead Sponsor
Roxane Laboratories
Target Recruit Count
29
Registration Number
NCT00674310

Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164

Phase 3
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2008-04-01
Last Posted Date
2013-05-06
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
76
Registration Number
NCT00650104
Locations
🇺🇸

GSK Investigational Site, Houston, Texas, United States

Effect of Ropinirole Hydrochloride in Progressive Myoclonic Epilepsy of Unverricht-Lundborg Type

Phase 2
Conditions
Unverricht-Lundborg Syndrome
First Posted Date
2008-03-19
Last Posted Date
2008-03-19
Lead Sponsor
University of Turku
Target Recruit Count
16
Registration Number
NCT00639119
Locations
🇫🇮

Turku university central hospital, Department of neurology, Turku, Finland

An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease

Phase 3
Completed
Conditions
Parkinson Disease
Parkinson's Disease
Interventions
First Posted Date
2008-03-11
Last Posted Date
2017-03-23
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
419
Registration Number
NCT00632736
Locations
🇬🇧

GSK Investigational Site, Swansea, United Kingdom

Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome

Phase 2
Completed
Conditions
Restless Legs Syndrome
Interventions
First Posted Date
2007-09-17
Last Posted Date
2018-09-26
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
35
Registration Number
NCT00530790
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole

Phase 2
Completed
Conditions
Parkinson Disease
First Posted Date
2007-04-13
Last Posted Date
2016-10-28
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
28
Registration Number
NCT00460148
Locations
🇿🇦

GSK Investigational Site, George, Eastern Cape, South Africa

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