ID
35647
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 Study Medication Record and Dose reduction form. Study Medication Record has to be filled in for Day 2, Week 1-52 and for early withdrawal. Dose reduction ha to be filled in for Week 1-48.
Mots-clés
Versions (1)
- 13/03/2019 13/03/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
13 mars 2019
DOI
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Licence
Creative Commons BY-NC 3.0
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Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS), 101468/192
Study Medication Record, Dose reduction
- StudyEvent: ODM
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