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ID
25903
Beschreibung
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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- 26.09.17 26.09.17 -
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26. September 2017
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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
L-dopa controlled study of ropinirole, neuroprotective effect and ophthalmological safety in early Parkinson’s disease 101468/125 Module 1 Screening
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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
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Centre Number
Item
Centre Number
integer
Patient Number
Item
Patient Number
integer
Patient Initials
Item
Patient Initials
text
Visit Date
Item
Visit Date
date
Date Informed Consent
Item
Record the date this consent was obtained
date
Date of birth
Item
Date of birth
date
CL Item
Male (1)
CL Item
Female (2)
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other (specify below) (4)
Specification of other race
Item
If other race, please specify
text
Height
Item
Height
float
Weight
Item
Weight
float
Sitting blood pressure systolic
Item
Sitting blood pressure systolic
integer
Sitting blood pressure diastolic
Item
Sitting blood pressure diastolic
float
Sitting heart rate
Item
Sitting heart rate
integer
Item Group
Date of onset of symptoms of parkinson´s disease
Date of onset of symptoms of parkinson´s disease
Item
Please give an approximate date of the onset of the patient´s Parkinson´s disease symptoms
date
Item Group
Modified Hoehn and Yahr Parkinsons Disease Staging
Item
Mark one of the stages below to indicate patient´s Hoehn and Yahr stage.
text
Code List
Mark one of the stages below to indicate patient´s Hoehn and Yahr stage.
CL Item
Stage 1 - Unilateral involvement, usually minimal or no functional impairment (1)
CL Item
Stage 1,5 - Unilateral plus axial involvement (2)
CL Item
Stage 2 - Bilateral or mid-line involvement, without impairment of balance. (3)
CL Item
Stage 2,5 - Mid bilateral disease, with recovery of balance on pull test (4)
CL Item
Stage 3 - First signs of impaired righting reflexes evident in unsteadier ess as the patient turns or demonstrated when he is pushed from standing equilibrium with feet together and eyes closed. Functionally somewhat restricted, but may be able to work, depending on nature of employment. Capable of independent living, with mild to moderate overall disability. (5)
CL Item
Stage 4 - Fully developed, severly disabling disease. Can stand and walk unaided but is markedly incapacitated. (6)
CL Item
Stage 5 - Confirmed to wheel-chair or bad with our assistance. (7)
Item Group
Significant medical / surgical history and physical examination
Item
Is the patient suffering from or has the patient ever suffered from any significant medical or surgical condition?
text
Code List
Is the patient suffering from or has the patient ever suffered from any significant medical or surgical condition?
CL Item
No (1)
CL Item
Yes -> If yes, please provide diagnosis below (2)
Item Group
Details on Significant medical or surgical condition
Diagnosis
Item
Diagnosis
text
Year of first diagnosis
Item
Year of first diagnosis
integer
CL Item
Past (1)
CL Item
Ongoing (2)
CL Item
No (1)
CL Item
Yes -> If "yes"record all anti-parkinson medication ever taken below. (2)
Drug Name
Item
Drug Name (Trade Name preferred)
text
Total daily dose
Item
Total daily dose (e.g. 500mg)
float
Medical Condition
Item
Medical Condition
text
Approximate Start Date
Item
Approximate Start Date
date
End Date
Item
End Date (if continuing leave blank)
date
Continuing
Item
Continuing
boolean
Item Group
Other prior medication (excluding anti-parkinson medication)
Item
Has the patient taken any medication (other than anti-parkinson medication) in the past month?
text
Code List
Has the patient taken any medication (other than anti-parkinson medication) in the past month?
CL Item
No (1)
CL Item
Yes -> If "yes" record details below. (2)
Item Group
Details on other prior medication (excluding anti-parkinson medication)
Drug Name
Item
Drug Name (Trade Name Preferred)
text
Total Daily Dose
Item
Total Daily Dose
float
Medical Condition
Item
Medical Condition
text
Approximate Start Date
Item
Approximate Start Date
date
End Date
Item
End Date (if continuing leave blank)
date
Continuing
Item
Continuing
boolean
Inclusion Criteria: Age
Item
1. Is the patient between 30 and 75 years of age?
boolean
Inclusion criteria: Fertility
Item
2. lf female, is the patient either post-menopausal, surgically sterilised or undergone a hysterectomy?
boolean
Inclusion criteria: idiopathic Parkinson´s disease
Item
3. Is the patient diagnosed as having idiopathic Parkinson's disease (Hoehn & 'l'ahr, stages I-II.5) based on medical history and neurological examination, and do they require dopaminergic therapy?
boolean
Inclusion Criteria: Informed Consent
Item
4. Has the patient given informed consent to participate in the study?
boolean
Inclusion criteria: Willingness to travel to the nearest PET scanning centre
Item
5. Is the patient able and willing to travel to the nearest PET scanning centre for two scans, and to the nearest ISCEV centre for electrophysiological examinations?
boolean
Exclusion Criteria: Parkinsonian symptomatology present longer than 2 years
Item
1. Has Parkinsonian symptomatology been present for longer than 2 years?
boolean
Exclusion criteria: L-dopa or dopamine agonist
Item
2. Has the patient previously received L-dopa or a dopamine agonist?
boolean
Exclusion Criteria: Severe head tremor
Item
3. Does the patient have severe head tremor which could preclude accurate elE ctrophysiological testing?
boolean
Exclusion Criteria: Clinically relevant abnormalities
Item
4. Does the patient have any abnormalities that the investigator deems to be clinically relevant, either on medical history or physical examination?
boolean
Exclusion Criteria: Severe dizziness
Item
5. Does the patient suffer severe dizziness or fainting due to postural hypotension on standing?
boolean
Exclusion Criteria: Severe systemic diseases
Item
6. Does the patient show any clinical evidence of severe systemic disease; relevant neoplastic disorders, including history of malignant melanoma; severe hepatic or renal disorders; diabetes of any severity or other severe endocrine disorder?
boolean
Exclusion Criteria: Mayor psychosis
Item
7. Is the patient suffering, or has the patient ever suffered from major psychosis (e.g. schizophrenia or psychotic depression - defined as patients scoring 3 or 4 on item 2 (thought disorder) or 3 (depression) of the UPDRS)?
boolean
Exclusion Criteria: Major psychosis
Item
7. Is the patient suffering, or has the patient ever suffered from major psychosis (e.g. schizophrenia or psychotic depression - defined as patients scoring 3 or 4 on item 2 (thought disorder) or 3 (depression) of the UPDRS)?
boolean
Exclusion Criteria: Severe clinical dementia
Item
8. Does the patient suffer from severe clinical dementia (eg. a score of 3 or 4 an item 1 (mentation) of the UPDRS)?
boolean
Exclusion Criteria: contraindications to L-dopa
Item
9. Does the patient have any contraindications to L-dopa?
boolean
Exclusion Criteria: recent alcoholism or drug dependence
Item
10. Does the patient have a recent history or current evidence of alcoholism or drug dependence?
boolean
Exclusion criteria: claustrophobia
Item
11. Does the patient suffer from claustrophobia?
boolean
Exclusion Criteria: Selegiline
Item
12. Is the patient receiving concomitant selegiline, or have they done so in the 6 weeks prior to screening?
boolean
Exclusion Criteria: Concomitant medication known or suspected retinal toxicity
Item
13. Is the patient receiving concomitant medication which has known or suspected retinal toxicity (eg. chloroquine)?
boolean
Exclusion Criteria: Difficulty with vision
Item
14. Is the patient unable to read a newspaper (with aided vision) or have difficulty with night vision?
boolean
Exclusion Criteria: Retinal degeneration or glaucoma
Item
15. Does the patient have retinal degeneration or glaucoma or have a family history of glaucoma or retinal degeneration?
boolean
Exclusion criteria: Visual field defect
Item
16. Is there evidence or known visual field defect?
boolean
Exclusion Criteria: Investigational drug
Item
17. Has the patient used an investigational drug with 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication (ie. run-in medication)?
boolean
Blood sample
Item
Take a blood sample for central laboratory evaluation. Was a sample taken?
boolean
Date blood sample taken
Item
If blood sample taken, record the sample date.
date
Item
Were there any clinically significant abnormal laboratory values from the screening sample?
text
Code List
Were there any clinically significant abnormal laboratory values from the screening sample?
CL Item
No (1)
CL Item
If "Yes" record findings on the Significant Medical/Surgical History and Physical Examination page. The patient is not eligible to continue in the study. (2)
End of visit instructions
Item
End of visit instructions: Dispense run-in medication pack and dosing instructions booklet. Arrange for the patient to return for the Baseline Visit in 1-2 weeks time.
boolean