Ropinirole has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Ropinirole Studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
105696 IV A Post-Marketing Surveillance to monitor the safety of RequipTM (Ropinirole hydrochloride) administered in Korean subjects according to the prescribing information
101468/173 IV Open study to evaluate the safety and efficacy of ropinirole (RequipÔ) in the treatment of new Parkinson Patients or Parkinson patients switching from another dopamine agonist.
Requip 101468/170 IV A follow-up study to observe the long term outcome of Parkinson’s disease in patients who completed Study SK&F 101468/056 or Study SK&F 101468/125.
RQ12003 IV Treatment of Parkinson’s disease subjects which are on L-dopa with adjunct treatment with ropinirole (ReQuip) in neurology outpatient department.
101468/090 III Compassionate use continuation of double-blind medication from ropinirole phase II & III studies or compassionate administration of open-label ropinirole in the treatment of Parkinson's disease
101468/124 III Open, Bromocriptine controlled study of Ropinirole at a flexible oral dose of 0.25-3.0mg T.I.D. in the treatment of Parkinsonian patients not optimally controlled on L-Dopa (DCI)
101468/127 III A Double-blind, Randomised, Bromocriptine-controlled Study of Ropinirole at a Flexible Oral Dose of 0.25-3.0mg Three Times Daily for 4 Months in the Treatment of Parkinsonian Patients (Hoehn and Yahr Stage II-IV) Not Optimally Controlled on L-dopa (DCI).
101468/172 III A randomized, 16-week open label, multicenter study of ropinirole to compare tolerability, initial treatment efficacy and patient quality of life of two doses titration schedules
101468/188 III A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS)
101468/190 III A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS)
101468/191 III A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Ropinirole in Subjects with Restless Legs Syndrome (RLS) Suffering from Periodic Leg Movements of Sleep (PLMS)
101468/192 III A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS)
101468/194 III A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS)
101468/243 III A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS)
101468/249 III A 12 Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS)
ROP101892 III A 12-Week, Double-Blind, Placebo-Controlled, Parallel-Group Study To Assess The Effectiveness Of Ropinirole In Patients Willing To Take Regular Medication For Their Restless Legs Syndrome In A Primary Care Setting
ROP105323 III A Randomized, Double-Blind, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.
ROX104805 III A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting from Ropinirole Immediate Release (IR) to Ropinirole Controlled Release for RLS (CR-RLS) Formulation (Formerly Ropinirole Extended Release [XR]) in Patients with Restless Legs Syndrome (RLS)
RRL100013 III A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage
RRL100310 III A 12 Week Double-blind, Placebo-controlled Study to Assess the Tolerability, Efficacy and Safety of Ropinirole Dosed PRN in Subjects with Restless Legs Syndrome (RLS) who Respond to Open-Label Treatment with Ropinirole. (TREAT RLS PRN).
RRL103660 III A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (CR-RLS) in RLS Patients with Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep
SK&F 101468-099 III An Open Study to Assess the Safety and Efficacy of Ropinirole at a Flexible Oral Dose of 0.25-8.0mg Three Times a Day for One Year in Parkinsonian Patients Not Optimally Controlled on L-Dopa
SK&F 101468-168 III A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapyin Subjects with Early Phase Parkinson’s Disease
SK&F-101468/169 III A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole CR as Adjunctive Therapy in Patients with Parkinson’s Disease who are not Optimally Controlled on L-dopa
SK&F101468/204 III A 12-Week, Randomized, Double-Blind, Parallel Group, Multicenter Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (CR-RLS) Tablets Compared with Ropinirole Immediate Release (IR) Tablets in Subjects with Restless Legs Syndrome (RLS)
SK&F-101468/228 III A Two-Year Phase IIIB Randomized, Multicenter, Double Blind, Sinemet® Controlled, Parallel Group, Flexible Dose Study, to Assess the Effectiveness of Controlled-release Ropinirole Add on Therapy to L-dopa at Increasing the Time to Onset of Dyskinesia in Parkinson's Disease Subjects
SKF 101468/044 III A Double-Blind, Placebo Controlled, Parallel Group Study of Oral Doses of Ropinirole for Six Months’ Treatment of Adjunct Therapy in Parkinsonian Patients Not Optimally Controlled on L-Dopa (DCI)
SKF 101468/054 III A Double-blind, Placebo Controlled, Parallel Group Study of Oral Doses of Ropinirole for Six Months in the Treatment of Early Parkinsonian Patients Not Receiving Dopaminergic Therapy
SKF 101468/056 III A Double-blind, L-dopa Plus Benserazide Controlled, Multicentre Study of Ropinirole at a Flexible Oral Dose of 0.25 – 8 mg Three Times Daily for Five Years in the Treatment of Early Parkinsonian Patients Not Treated with L-Dopa.
SKF-101468/043 III A Double-Blind, Bromocriptine Controlled, Multicenter Study of Ropinirole at a Flexible Oral Dose of 0.25–8.0mg Three Times Daily for Six Months in the Treatment of Parkinsonian Patients Not Optimally Controlled on L-Dopa
SKF-101468/044 and SKF-101468/054 III Population Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Relationship of Ropinirole in Parkinsonian Patients
SKF101468/053 III A Double-blind, Bromocriptine Controlled, Multicentre Study of Ropinirole at a Flexible Oral Dose of 0.25-8 mg Three Times Daily for Three Years in the Treatment of Early Parkinsonian Patients Not Treated with L-dopa
SKF-101468/125 III A double-blind, multicentre, flexible dose, L-dopa controlled study of ropinirole to investigate A) neuroprotective effect as measured by 3D PET scanning, and B) ophthalmological safety, in patients with early Parkinson’s disease
101468/032 II Anti-Parkinson Efficacy of Ropinirole (SKF 101468) versus Placebo as Monotherapy in Parkinson's Disease
101468/063 II A repeat dose, steady state study to determine the effect of food on the pharmacokinetics of Ropinirole in Parkinson patients.
101468/102 II A study to investigate the effect of repeated oral doses of ciprofloxacin on steady state ropinirole pharmacokinetics in Parkinsonian patients.
101468/207 II A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen of ropinirole in patients suffering from Restless Legs Syndrome (RLS)
101468/218 II A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS)
999910/188 II Effects of Dopaminergic Agonist Treatment on Spinal Cord Excitability in Restless Legs Syndrome
Requip 101468/164 II An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole CR and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole CR formulation in early stage Parkinson’s disease subjects
ROF102100 II A randomised, double-blind, placebo-controlled, parallel group study to investigate the safety and efficacy of controlled-release ropinirole (CR) (1-24mg) administered once daily for 12 weeks in subjects with fibromyalgia.
ROP109087 II An open label, repeat dose, dose escalation study conducted in Parkinson’s disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/XL) 12 mg tablets
SK&F 101468/062 II An open study to assess the pharmacokinetic interaction at steady state following multiple oral dosing, between Ropinirole (2 MG TDS) and L-Dopa (100 MG BD) (+ Decarboxylase Inhibitor) in L-Dopa naïve (De Novo) patients with Parkinson’s disease.
SK&F- 101468/165 II An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies.
SK&F-101468/101 II A study to investigate the effect of steady state oral theophylline on the pharmacokinetics of ropinirole at steady state and the effect of steady state ropinirole on the pharmacokinetics of a single intravenous dose of theophylline in Parkinsonian patients.
SKF 101468/167 II A Phase II, randomized, double-blind, active-controlled study to determine the optimal initial titration regimen of ropinirole CR tablets in Parkinson's disease subjects not receiving other dopaminergic therapies.
SKF-101468/166 II A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum welltolerated starting dose of ropinirole controlled-release (CR) in Parkinson's Disease patients not receiving other dopaminergic therapies
101468 001 I A single blind assessment of the safety and effects on serum prolactin and on cardiovascular function of oral administration of a range of doses (10µg to 2.5 mg) of a solution of SK&F101468 in healthy male volunteers.
101468 016 I A Single Blind Study to Investigate the Effect of Ropinirole at Steady State on Plasma Concentrations of Digoxin in Parkinsonian Patients
101468/005 I A double-blind, placebo-controlled, crossover study to assess the CNS effects of SK&F 101468 in normal volunteers using quantitative pharmaco-EEG and topographical coloured dynamic brain mapping techniques.
101468/012 (A9905-GER) I A Study to Assess the Acute Effects of a Standard Meal on the Plasma Pharmacokinetics of SK&F 101468, After Administration of a Single Oral Dose of 800µg SK&F 101468 in Normal Man
101468/A9903-UK (SK&F 101468-011) I A Study to Investigate the Pharmacokinetics and to Profile the Metabolites of 14C SK&F 101468 When Administered by the Intravenous and Oral Route to Healthy Male Subjects
101468-003 I A single blind placebo controlled rising dose study of the effects of oral SK&F101468 (250 µg to 1000µg) on supine and erect blood pressure and plasma catecholamines in healthy male volunteers.
101468-009 I An open study to investigate the tolerance and preliminary pharmacokinetics of single intravenous doses of 100, 200, 400, 600 and 800 mg SK&F 101468 following domperidone pre-treatment (20 mg t.i.d.) in healthy male volunteers
101468-010 (A9902-GER) I The effects of a single dose of 20 mg domperidone on the pharmacokinetic, safety and pharmacodynamic responses to a single dose of 800 mcg SK&F101468, in healthy volunteers.
Requip 101468/163 I A double-blind, two-way cross-over, placebo-controlled single dose and repeat dose study to investigate the pharmacokinetics of ropinirole after single and multiple doses of a CR-formulation in healthy male and female subjects
Requip 101468/219 I An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers
SK&F 101468/061 I An open, randomised three-way crossover study to investigate the relative and absolute bioavailability of ropinirole following domperidone pretreatment in healthy male volunteers.
SK&F-101468/199 I An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole
SK&F-101468/201 I A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole
SKF-101468/161 I A single dose study to compare the pharmacokinetics of ropinirole from three controlled release (CR) test formulations with the immediate release (IR) reference formulation in healthy male volunteers and to assess the influence of food and domperidone on one of the test formulations
SKF-101468/162 I A four-way cross-over, placebo- and IR-controlled study to compare the single-dose pharmacokinetics of ropinirole from CR-formulations (doses of 0.75 mg and 3 mg) and from the IR formulation in healthy male and female volunteers
SKF-101468/197 I An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers
SKF-101468/198 I An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation
SKF-101468/902 I A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control.