ID
26766
Description
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
Keywords
Versions (1)
- 10/24/17 10/24/17 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 24, 2017
DOI
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License
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 2 Visit 5 Month 3
L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 2 Visit 5 Month 3
Description
Flexible Dose Start Date and Current Dose Level
Description
Vital signs
Description
Sitting Blood Pressure
Data type
integer
Measurement units
- mmHg
Description
Sitting Blood Pressure
Data type
integer
Measurement units
- mmHg
Description
Sitting Heart Rate
Data type
integer
Measurement units
- beats/min
Description
Concomitant Medication
Description
Adverse Experiences
Description
Transcribe any ongoing adverse experiences from the previous module, record any changes to ongoing adverse experiences, and details of any new adverse experiences observed or reported by the patient in the Adverse Experiences section towards the back of this module.
Data type
boolean
Description
Study Medication Compliance
Description
Compliance is defined as taking between approximately 80-120% of medication.
Data type
integer
Description
End of visit instructions for patients continuing
Data type
text
Description
End of visit constructions for patients not continuing
Data type
text
Description
Concomitant medication
Description
Permitted Concomitant medication
Data type
text
Description
Transcribe any ongoing concomitant medication from the previous module, and record any concomitant medication changes since the last visit. Any new medical illness/diagnosis or symptoms in the absence of a diagnosis should be recorded in the Adverse Experience section utilising the same terminology. lf a medication was marked 'Continuing' at the last visit, but has since had a dosage change or has been stopped, it must be recorded as a change with the start and end date.
Data type
boolean
Description
Details of Concomitant Medication
Description
Drug Name
Data type
text
Description
Total Daily Dose
Data type
integer
Measurement units
- mg
Description
Medical Condition
Data type
text
Description
Approximate Start Date
Data type
date
Description
End Date
Data type
date
Description
Continuing
Data type
boolean
Description
For SB
Data type
text
Description
Levodopa rescue
Description
Patients must complete as a minimum the initial dose level 5. Titration of the dose of study medication to the maximum tolerated dose is encouraged. However if the patient´s symptoms remain inadequately controlled, open label L-dopa may be prescribed as a rescue medication.
Data type
text
Description
Levodopa - Rescue Therapy
Data type
text
Description
Levodopa - Rescue Therapy
Data type
text
Description
Primary reason
Data type
text
Description
Details of Ledopa Rescue Therapy
Description
Adverse Experiences
Description
Details on adverse experiences
Description
Experience
Data type
text
Description
For SB
Data type
text
Description
Date started
Data type
date
Description
Date stopped
Data type
date
Description
Duration if if less than 24 hrs
Data type
integer
Description
Experience continuing
Data type
boolean
Description
Course
Data type
boolean
Description
Number of episodes
Data type
integer
Description
Intensity
Data type
text
Description
Action taken on Study Medication
Data type
text
Description
Suspected relationship
Data type
text
Description
Corrective therapy
Data type
integer
Description
Serious adverse experience
Data type
boolean
Description
AEGIS
Data type
text
Description
Investigator´s signature
Data type
text
Description
Patient Continuation/Withdrawal
Description
Patient Continuation/Withdrawal
Data type
integer
Description
Most appropriate reason for withdrawal
Data type
integer
Description
Specification of other
Data type
text
Description
Date of last dose
Data type
date
Description
Investigator´s signature
Data type
text
Description
Date
Data type
date