ID

26222

Beschrijving

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

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Versies (1)
  1. 12-10-17 12-10-17 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 oktober 2017

DOI

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Creative Commons BY-NC 3.0
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L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 1 Screening/Baseline Conclusion

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

1 Formulieren  
Screening Baseline Conclusion
Beschrijving

Screening Baseline Conclusion

Will the patient be continued in the study?
Beschrijving

Will the patient be continued in the study?

Datatype

integer

If withdrawn, please mark primary reason below.
Beschrijving

Primary reason for withdrawal

Datatype

text

If other reason for withdrawal, please specify
Beschrijving

Specification of other reason for withdrawal

Datatype

text

Investigator´s signature
Beschrijving

Investigator´s signature

Investigator´s signature
Beschrijving

I certify that I have reviewed the data in this case report form up to this point and that all the information is complete and accurate.

Datatype

text

Date
Beschrijving

Date

Datatype

date

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Screening Baseline Conclusion
Item
Will the patient be continued in the study?
integer
Will the patient be continued in the study?
Code List
Will the patient be continued in the study?
CL Item
Yes (1)
CL Item
No (If No, please mark the PRIMARY reason of exclusion/withdrawal below) (2)
Item
If withdrawn, please mark primary reason below.
text
Primary reason for withdrawal
Code List
If withdrawn, please mark primary reason below.
CL Item
Baseline adverse experience (Complete BAE form) (1)
CL Item
Does not meet inclusion/exclusion criteria (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other, specify... (5)
Specification of other reason for withdrawal
Item
If other reason for withdrawal, please specify
text
Item Group
Investigator´s signature
Investigator´s signature
Item
Investigator´s signature
text
Date
Item
Date
date
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