ID

35621

Description

Study ID: 101468/192 Clinical Study ID: 101468/192 Study Title:A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) 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; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The study consists of 16 visits which are devided in 3 study books: Book 1: Screening (+Baseline), Day 2, Week 1, Week 2 , Week 3 , Week 4, Week 5, Week 6, Week 7, Week 8 Book 2: Week 12, Week 24, Week 36, Week 48, Week 52, Follow-up Book 3: Early withdrawal and Follow-up Each follow-up Visit takes place 7 +/- 3 days after last dose This document contains the checklist (Concomitant Medication, Medical Procedure, RLS Rating, Adverse Experiences, CGI Rating and Exclusion criterion) form. Exclusion criterion has to be filled in only for baseline. RLS Rating and CGI Rating have to be checked for each visit. Medical procedure, concomitant medication and adverse experience have to be checked for: Screening/Baseline, Day 2, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 52, Early withdrawal and Follow-up

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1. 12/03/2019 12/03/2019 -

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GlaxoSmithKline

Téléchargé le

12 mars 2019

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