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Prior Parkinson’s Medication Screening Ropinirole Parkinson Disease 101468/165 - Prior Parkinson’s Medication Screening

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 11 Dataelement, 1 Språk
Item-grupp: Medication Parkinson Disease
Study Part: Prior Parkinson’s Medication Screening. 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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Random Drug Screening (Urine) Week 5 PK Visit (Visit 9) Ropinirole Parkinson Disease 101468/165 - Random Drug Screening (Urine) Week 5 PK Visit (Visit 9)

- 2021-09-20 - 1 Formulär, 1 Item-grupp, 8 Dataelement, 1 Språk
Item-grupp: DRUG SCREENING (URINE)
Study Part: Random Drug Screening (Urine) Week 5 PK Visit (Visit 9). 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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201 - AE/ Concomitant Medication Probe

- 2019-06-19 - 1 Formulär, 2 Item-grupper, 6 Dataelement, 1 Språk
Item-grupper: Administrative Data, AE, Concomitant Medication
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 AE/ Concomitant Medication Probe form. It has to be filled in for each study day (Day1-Day19) and for Follow-up.

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

- 2019-06-19 - 1 Formulär, 2 Item-grupper, 6 Dataelement, 1 Språk
Item-grupper: Administrative Data, Dosing Details
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 Dosing Details form. It has to be filled in for Week 1, Week 2 and Week 3.

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

- 2019-05-10 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Administrative Data, Concomitant Medication
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 concomitant medication form. It has to be filled in if the subject takes concomitant medication during the study.

27920_Visit 1 EpimiRNA Study D Vagal Nerve Stimulation NCT02359188 - Visit 1 EpimiRNA Study D Vagal Nerve Stimulation NCT02359188

- 2017-12-19 - 1 Formulär, 7 Item-grupper, 21 Dataelement, 1 Språk
Item-grupper: Administrative data, First blood sample, Attachment of ear electrode of tVNS device, Test meal, Second blood sample, Adverse events and comments, Signature physician
NCT02359188 Influence of Transcutaneous Vagal Nerve Stimulation on Expression of microRNA, Cytokines, Chemokines and Neuropeptides as Well as Cerebral Resting State and Gastric Motility Quellenangabe: Dr. Sebastian Bauer Philipps-Universität Marburg

27924_Visit 2 EpimiRNA Study D Vagal Nerve Stimulation NCT02359188 - Visit 2 EpimiRNA Study D Vagal Nerve Stimulation NCT02359188

- 2017-12-19 - 1 Formulär, 8 Item-grupper, 25 Dataelement, 1 Språk
Item-grupper: Administrative data, First blood sample, tVNS / sham-tVNS, Test meal, Second blood sample, MRI, Adverse events and comments, Signature physician
NCT02359188 Influence of Transcutaneous Vagal Nerve Stimulation on Expression of microRNA, Cytokines, Chemokines and Neuropeptides as Well as Cerebral Resting State and Gastric Motility Quellenangabe: Dr. Sebastian Bauer Philipps-Universität Marburg

Medication and food diary Ropinirole CR Ropinirole IR Monotherapy 101468/168

- 2017-12-06 - 1 Formulär, 3 Item-grupper, 16 Dataelement, 1 Språk
Item-grupper: administrative data, Medication and food diary before clinic visit, Medication and food diary
Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy 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: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Visit 2 EpimiRNA Study D Vagal Nerve Stimulation NCT02359188

- 2017-12-05 - 1 Formulär, 8 Item-grupper, 25 Dataelement, 1 Språk
Item-grupper: Administrative data, First blood sample, tVNS / sham-tVNS, Test meal, Second blood sample, MRI, Adverse events and comments, Signature physician
NCT02359188 Influence of Transcutaneous Vagal Nerve Stimulation on Expression of microRNA, Cytokines, Chemokines and Neuropeptides as Well as Cerebral Resting State and Gastric Motility Quellenangabe: Dr. Sebastian Bauer Philipps-Universität Marburg

Concomitant Medication Treatment Phase Ropinirole Parkinson Disease 101468/165 - Concomitant Medication Treatment Phase

- 2017-11-19 - 1 Formulär, 1 Item-grupp, 9 Dataelement, 1 Språk
Item-grupp: Concomitant Medication
Study part: Concomitant Medication Treatment Phase. 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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Dosing Details Week 5 PK Visit (Visit 9) Ropinirole Parkinson Disease 101468/165 - Dosing Details Week 5 PK Visit (Visit 9)

- 2017-10-23 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Dosing
Study Part: Dosing Details Week 5 PK Visit (Visit 9). 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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Dosing Details Week 4 PK Visit (Visit 8) Ropinirole Parkinson Disease 101468/165 - Dosing Details Week 4 PK Visit (Visit 8)

- 2017-10-23 - 1 Formulär, 1 Item-grupp, 5 Dataelement, 1 Språk
Item-grupp: Dosing
Study Part: Dosing Details Week 4 PK Visit (Visit 8). 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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

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