Home > Result Summaries: Compounds > Ropinirole Result Summaries: Ropinirole GSKStudy ID Phase Title Summary (Download) 100013 Phase 3 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 (0 citation(s)) 100310 Phase 3 A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS) (0 citation(s)) 101468/001 Phase 1 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. (1 citation(s)) 101468/003 Phase 1 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. (0 citation(s)) 101468/004 Phase 1 Effect of chronic administration of carvedilol, 6.25mg to 25mg b.i.d., on renal hemodynamics in mild to moderate essential hypertension. (0 citation(s)) 101468/005 Phase 1 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. (0 citation(s)) 101468/009 Phase 1 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. (0 citation(s)) 101468/010 Phase 1 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. (1 citation(s)) 101468/011 Phase 1 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 (1 citation(s)) 101468/012 Phase 1 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 800g SK&F 101468 in Normal Man (1 citation(s)) 101468/016 Phase 1 A Single Blind Study to Investigate the Effect of Ropinirole at Steady State on Plasma Concentrations of Digoxin in Parkinsonian Patients. (1 citation(s)) 101468/032 Phase 2 Anti-Parkinson Efficacy of Ropinirole (SKF 101468) versus Placebo as Monotherapy in Parkinson's Disease (3 citation(s)) 101468/043 Phase 3 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 (1 citation(s)) 101468/044 Phase 3 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) (2 citation(s)) 101468/044 and SKF-101468/054 Phase 3 Population Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Relationship of Ropinirole in Parkinsonian Patients (0 citation(s)) 101468/053 Phase 3 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 (1 citation(s)) 101468/054 Phase 3 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 (14 citation(s)) 101468/056 Phase 3 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. (1 citation(s)) 101468/061 Phase 1 An open, randomised three-way crossover study to investigate the relative and absolute bioavailability of ropinirole following domperidone pretreatment in healthy male volunteers. (0 citation(s)) 101468/062 Phase 2 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. (0 citation(s)) 101468/063 Phase 2 A repeat dose, steady state study to determine the effect of food on the pharmacokinetics of Ropinirole in Parkinson patients. (0 citation(s)) 101468/090 Phase 3 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 (0 citation(s)) 101468/099 Phase 3 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 (0 citation(s)) 101468/101 Phase 2 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. (1 citation(s)) 101468/102 Phase 2 A study to investigate the effect of repeated oral doses of ciprofloxacin on steady state ropinirole pharmacokinetics in Parkinsonian patients. (1 citation(s)) 101468/124 Phase 3 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) (1 citation(s)) 101468/125 Phase 3 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 (3 citation(s)) 101468/127 Phase 3 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). (0 citation(s)) 101468/161 Phase 1 A single dose study to compare the pharmacokinetics of ropinirole from three new formulations with the standard rmarketed reference formulation in healthy male volunteers and to assess the influence of food and domperidone on one of the new formulations (0 citation(s)) 101468/162 Phase 1 A four-way cross-over, placebo- and standard formulation -controlled study to compare the single-dose pharmacokinetics of ropinirole from new formulations and from the standard formulation in healthy male and female volunteers (0 citation(s)) 101468/163 Phase 1 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. (0 citation(s)) 101468/164 Phase 1 An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects (0 citation(s)) 101468/165 Phase 2 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 8 mg) compared to the ropinirole CR (4 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. (0 citation(s)) 101468/166 Phase 2 A Phase II, randomised, double-blind, active-controlled, dose-escalation study to determine the maximum well-tolerated starting dose of a new formulation of ropinirole in Parkinson's Disease patients not receiving other dopaminergic therapies (0 citation(s)) 101468/167 Phase 2 A Phase II, randomized, double-blind, active-controlled study to determine the optimal initial titration regimen of a new formulation of ropinirole in Parkinson's disease subjects not receiving other dopaminergic therapies. (0 citation(s)) 101468/168 Phase 3 A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy (4 citation(s)) 101468/169 phase 3 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 (14 citation(s)) 101468/170 Phase 4 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. (5 citation(s)) 101468/172 Phase 3 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 (0 citation(s)) 101468/173 Phase 4 Open study to evaluate the safety and efficacy of ropinirole (Requip) in the treatment of new Parkinson Patients or Parkinson patients switching from another dopamine agonist. (0 citation(s)) 101468/180 Phase 3 A clinical evaluation of ropinirole hydrochloride (SK&F101468) used jointly with L dopa for Parkinson's Disease - a double-blind group comparative trial with placebo as comparison (1 citation(s)) 101468/182 Phase 3 Clinical Evaluation of Ropinirole HCl (SK&F101468) as Monotherapy in Parkinson’s Disease – Phase III Open-label Uncontrolled Study – (0 citation(s)) 101468/188 Phase 3 A Study of the Maintained Efficacy and Safety of Ropinirole Versus Placebo in the Long Term Treatment of Restless Legs Syndrome (RLS) (3 citation(s)) 101468/190 Phase 3 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). (1 citation(s)) 101468/191 Phase 3 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) (1 citation(s)) 101468/192 Phase 3 A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) (1 citation(s)) 101468/194 Phase 3 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). (1 citation(s)) 101468/196 phase 3 101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients with Parkinson's Disease who Completed the Previous Ropinirole CR Studies 167 or 164 (1 citation(s)) 101468/197 Phase 1 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 (0 citation(s)) 101468/198 Phase 1 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 (0 citation(s)) 101468/199 Phase 1 An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole (0 citation(s)) 101468/201 Phase 1 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 (0 citation(s)) 101468/204 phase 3 A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared with Ropinirole Immediate Release (IR) Tablets in Subjects with Restless Legs Syndrome (RLS) (0 citation(s)) 101468/205 Phase 3 A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome (0 citation(s)) 101468/206 phase 3 A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS) (1 citation(s)) 101468/207 Phase 2 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). (0 citation(s)) 101468/218 Phase 2 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) (3 citation(s)) 101468/219 Phase 1 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 (0 citation(s)) 101468/228 phase 3 A two year Phase IIIb randomised, 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. (3 citation(s)) 101468/243 Phase 3 A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) (1 citation(s)) 101468/248 phase 3 An Open-Label Extension Study with REQUIP (ropinirole) CR for Subjects from Studies 101468/165, 101468/168 and 101468/169 (0 citation(s)) 101468/249 phase 3 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) (0 citation(s)) 101468/253 phase 1 An open label, single dose, dose rising, multi-centre study to assess the tolerability and pharmacokinetics of Ropinirole Immediate Release in adolescent patients with RLS. (0 citation(s)) 101468/902 Phase 1 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. (0 citation(s)) 101892 Phase 3 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 (0 citation(s)) 106066 phase 3 Clinical Evaluation of ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in subjects with advanced Parkinson’s disease (0 citation(s)) 106207 phase 4 An open-label, multi-centre, observational, post-marketing surveillance to monitor the safety of REQUIP(ropinirole) administered in Korean restless leg syndrome patients according to the prescribing information (1 citation(s)) 107846 phase 2 Clinical Evaluation of Ropinirole CR-RLS Tablets in Restless Legs Syndrome-Open-Label, Uncontrolled Study. Classification: Clinical Pharmacology, Exploratory (1 citation(s)) 108862 phase 4 Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients with Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety - (1 citation(s)) 111528 phase 3 A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment with Ropinirole PR as Adjunctive Therapy in Patients with Parkinson’s Disease who are not optimally controlled on L-Dopa (0 citation(s)) 111905 phase 4 Observational survey on diagnosis and treatment of M. Parkinson (0 citation(s)) 112310 phase 4 Special Drug Use Investigation for ReQuip Tablet (Long-term:Parkinson's Disease) (0 citation(s)) 112558 phase 1 A single dose and repeat dose study to investigate the pharmacokinetics of ropinirole after single and multiple doses of a PR-formulation in Chinese healthy male and female subjects (0 citation(s)) 112771 phase 1 An open label study conducted in healthy subjects to demonstrate bioequivalence between ropinirole prolonged release tablets (ropinirole XL, marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) manufactured at Crawley and Aranda (1 citation(s)) 113079 phase 2 Clinical evaluation of ropinirole IR (immediate release) tablets in patients who are diagnosed with symptomatic restless legs syndrome (RLS) associated with Chronic kidney disease (CKD) managed with haemodialysis (including haemofiltration and haemodiafiltration) (1 citation(s)) 114236 Phase 2 Meta Analysis Summary for Disclosure of SK&F101468 Study ROR114236: Suicidality Evaluation of Ropinirole in Restless Legs Syndrome (0 citation(s)) 114463 phase 3 An Open Label Extension Study with REQUIP PR for subjects from study ROP111528 (0 citation(s)) 115168 n\a PGx366 Pharmacogenetics study of sleep-related phenotypes in subjects from ropinirole clinical studies RRL100013, 101468/204, 101468/205, ROX104805, ROR104836, ROP106064, 108862, ROX107846 (0 citation(s)) 99910/188 Phase 2 Effects of Dopaminergic Agonist Treatment on Spinal Cord Excitability in Restless Legs Syndrome (0 citation(s)) ROF102100 Phase 2 A randomised, double blind, placebo-controlled, parallel group study to investigate the safety and efficacy of controlled-release ropinirole (CR) (1-24 mg) administered once daily for 12 weeks in subjects with fibromyalgia (0 citation(s)) ROP105323 phase 3 A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. (0 citation(s)) ROP105696 Phase 3 A Post-Marketing Surveillance to monitor the safety of RequipTM (Ropinirole hydrochloride) administered in Korean subjects according to the prescribing information (0 citation(s)) ROP106064 phase 2 Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study - (0 citation(s)) ROP109087 phase 2 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/CR) 12mg tablets. (1 citation(s)) ROR104836 phase 4 A parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome. (1 citation(s)) ROX104805 phase 3 A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting from Ropinirole Immediate Release (IR) to Ropinirole Extended Release (XR) Formulation in Patients with Restless Legs Syndrome (RLS) (0 citation(s)) RQ12003 Phase 4 Treatment of Parkinson’s disease subjects which are on L-dopa with adjunct treatment with ropinirole (ReQuip) in neurology outpatient department. (0 citation(s)) RRL103628 Phase 1 An Open-Label, Parallel-Group, Repeat-Dose Study to Investigate the Effects of End Stage Renal Disease and Haemodialysis on the Pharmacokinetics of Ropinirole (Study RRL103628) (0 citation(s)) RRL103660 phase 4 A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients with Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep (0 citation(s)) RRL106721 phase 3 A multicenter 3:1-randomized placebo-controlled double-blind Phase IIIb study on the effects of Ropinirole on mood/(subclinical) depression in the therapy of patients with moderate to severe idiopathic RLS in Germany (0 citation(s))
