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Anxiety And Depression Scale (HADS) Ropinirole Restless Legs Syndrom NCT00355641 - Anxiety And Depression Scale

- 27/9/21 - 1 formulario, 1 itemgroup, 1 item, 1 idioma

Itemgroup: Hospital anxiety and depression scale

Study part: Anxiety And Depression Scale. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. Phase: phase 3. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP, Zygara; Zygara, ZIPEREVE, ZEPREVE, Requip Depot, REQUIP, REPREVE, Modutab, ADARTREL. Study Indication : Restless Legs Syndrome. Study ID: 101468/206. Clinical Study ID: 101468/206.

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 - Module 3 Visit 6 Month 6

- 20/12/17 - 1 formulario, 18 itemgroups, 51 items, 1 idioma

Itemgroups: Current Dose Level, Vital signs, Concomitant Medication, Adverse Experiences, L-Dopa Rescue, Study Medication Compliance, End of visit instructions for patients continuing, End of visit instructions for patients not continuing, ERG Examintion Appointment Card, Concomitant Medication, Details on concomitant medication, Levodopa Rescue Therapy, Details on Levodopa - rescue therapy, Adverse Experiences, Details on Adverse Experiences, Investigator´s Signature, Patient Continuation / Withdrawal, Investigator´s Signature

Study ID: 101468/125 Clinical Study ID: SKF-101468/125 Study Title: 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 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 2 Visit 5 Month 3

- 24/10/17 - 1 formulario, 13 itemgroups, 52 items, 1 idioma

Itemgroups: General information, Flexible Dose Start Date and Current Dose Level, Vital signs, Concomitant Medication, Adverse Experiences, Study Medication Compliance, Concomitant medication, Details of Concomitant Medication, Levodopa rescue, Details of Ledopa Rescue Therapy, Adverse Experiences, Details on adverse experiences, Patient Continuation/Withdrawal

Study ID: 101468/125 Clinical Study ID: SKF-101468/125 Study Title: 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 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 1 Patient Continuation / Withdrawal - L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 1 Patient Continuation / Withdrawal

- 12/10/17 - 1 formulario, 1 itemgroup, 6 items, 1 idioma

Itemgroup: Patient continuation / withdrawal

Study ID: 101468/125 Clinical Study ID: SKF-101468/125 Study Title: 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 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 1 Concomitant Medication/Adverse Experiences

- 12/10/17 - 1 formulario, 5 itemgroups, 24 items, 1 idioma

Itemgroups: Concomitant Medication Information, Concomitant Medication, Adverse Experiences, Adverse Experience Details, Investigator´s Signature

Study ID: 101468/125 Clinical Study ID: SKF-101468/125 Study Title: 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 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Neurological Examination Early Withdrawal Ropinirole Case Report Form GSK RRL100013

- 1/10/17 - 1 formulario, 1 itemgroup, 19 items, 1 idioma

Itemgroup: Neurological Examination

Neurological Examination Early Withdrawal Ropinirole Case Report Form GSK Study ID: 100013 Clinical Study ID: RRL100013 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

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201 - Pregnancy Notification Form

- 10/5/19 - 1 formulario, 8 itemgroups, 58 items, 1 idioma

Itemgroups: Administrative Data, Reporter information, Medical history mother, Medical history father, Concomitant Medication, PREGNANCY INFORMATION, Infant information, LABORATORY TESTS

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: 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 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Pregnancy Notification Form. It has to be filled in for each patient who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail or fax (fax preferred) within two weeks of learning of the pregnancy. After delivery complete the remaining sections and fax the form to GSK. Original pages should remain with the subject’s Case Report Form.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198 - Pregnancy Notification Form

- 16/4/19 - 1 formulario, 8 itemgroups, 55 items, 1 idioma

Itemgroups: Administrative data, Reporter Information, Mother's relevant medical/family history, Father's relevant medical/family history, GSK Drug/Vaccine Information and Concomitant Medications, Current pregnancy information/status, Infant information, Relevant Laboratory Test and Procedures

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title: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 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Pregnancy Notification Form form. Complete as may sections ofthis form for each subject who becomes pregnant during the study period. Send a copy of the form to GlaxoSmithKline (GSK will provide separately a list of contact names and information) by mail of fax (fax preferred) within two weeks ofleaming ofthepregnancy.After delivery complete the remaining sections and fax the form to GSK. Original pages should remain with the subject's Case Report From.

screening medical history PK and tolerability of ropinirole as 5 new formulations 101468/197

- 4/9/17 - 1 formulario, 18 itemgroups, 69 items, 1 idioma

Itemgroups: administrative data, ear, nose, throat, eyes, respiratory system, cardiovascular system, gastrointestinal system, hepatobiliary system, pancreas, urology, reproduction system, neurology, blood and lymphatic system, endocrine and metabolic system, musculoskeletal system, skin, psychiatry, allergies, others, investigator

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title: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 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome

Profile of Mood State Brief Form (POMSB) Ropinirole Restless Legs Syndrom NCT00355641 - Profile of Mood State Brief Form

- 5/8/17 - 1 formulario, 1 itemgroup, 1 item, 1 idioma

Itemgroup: score psychological

Study part: Profile of Mood State Brief Form. A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Clinicaltrials.gov Identifier: NCT00355641. Phase: phase 3. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP, Zygara; Zygara, ZIPEREVE, ZEPREVE, Requip Depot, REQUIP, REPREVE, Modutab, ADARTREL. Study Indication : Restless Legs Syndrome. Study ID: 101468/206. Clinical Study ID: 101468/206.

Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902) - Pharmacogenetic Research; Prior Medication; Baseline Signs and Symptoms

- 27/9/21 - 1 formulario, 6 itemgroups, 32 items, 1 idioma

Itemgroups: Administrative, Pharmacogenetic Research, Prior Medication, Prior Medication , Baseline Signs and Symptoms, Baseline Signs and Symptoms - Investigator's Signature

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title: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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Prior Medication

- 20/9/21 - 1 formulario, 3 itemgroups, 11 items, 1 idioma

Itemgroups: Administrative, Prior Medication, Prior Medication

Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title: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) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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