ID

36155

Beschreibung

Evaluating the Effectiveness of Neupro® (Rotigotine) and L-dopa Combination Therapy in Patients With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02227355

Link

https://clinicaltrials.gov/show/NCT02227355

Stichworte

Versionen (1)
  1. 18.04.19 18.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. April 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT02227355

Englisch

Eligibility Idiopathic Parkinson's Disease NCT02227355

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
the following selection criteria must be followed for patients entering the noninterventional study (nis):
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
the decision by the treating physician to prescribe rotigotine transdermal patch is made before participating in the nis due to a clinical therapeutic indication (e.g., because of intolerance and/or ineffectiveness of another dopamine agonist)
Beschreibung

Indication Rotigotine Transdermal Patch | Intolerance to Dopamine Agonists Other | Lack of Efficacy Dopamine Agonists Other

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1700683
UMLS CUI [1,3]
C2348814
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0178601
UMLS CUI [2,3]
C0205394
UMLS CUI [3,1]
C0235828
UMLS CUI [3,2]
C0178601
UMLS CUI [3,3]
C0205394
the patient is either male or female and over 18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
a patient data consent form is signed and dated by the patient or by the legal representative
Beschreibung

Informed Consent | Informed Consent Patient Representative

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
the patient has idiopathic parkinson's disease, has not received rotigotine within 28 days prior to the baseline visit and is willing to participate in questionnaire based assessments
Beschreibung

Parkinson Disease | Rotigotine Absent | Participation Questionnaire

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C1700683
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C0034394
the patient is receiving l-dopa as monotherapy or a combination therapy composed of l-dopa and a dopamine agonist other than rotigotine
Beschreibung

Levodopa | Combined Modality Therapy | Dopamine Agonists | Exception Rotigotine

Datentyp

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0178601
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1700683
the patient has been on l-dopa therapy for at least 6 months and is responding to initial l-dopa therapy
Beschreibung

Levodopa | Disease Response

Datentyp

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C1704632
the patient has a hoehn and yahr stage score of 1 to 4.
Beschreibung

MDS-UPDRS - Hoehn and Yahr Stage

Datentyp

boolean

Alias
UMLS CUI [1]
C3639483
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded from the study if they have participated in a clinical study of a medication or a medical device within 3 months prior to baseline or if they are participating in a clinical study at the time of inclusion or have already participated in the current study.
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
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Ähnliche Modelle

Eligibility Idiopathic Parkinson's Disease NCT02227355

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
the following selection criteria must be followed for patients entering the noninterventional study (nis):
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Indication Rotigotine Transdermal Patch | Intolerance to Dopamine Agonists Other | Lack of Efficacy Dopamine Agonists Other
Item
the decision by the treating physician to prescribe rotigotine transdermal patch is made before participating in the nis due to a clinical therapeutic indication (e.g., because of intolerance and/or ineffectiveness of another dopamine agonist)
boolean
C3146298 (UMLS CUI [1,1])
C1700683 (UMLS CUI [1,2])
C2348814 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0178601 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0235828 (UMLS CUI [3,1])
C0178601 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
Age
Item
the patient is either male or female and over 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
a patient data consent form is signed and dated by the patient or by the legal representative
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Parkinson Disease | Rotigotine Absent | Participation Questionnaire
Item
the patient has idiopathic parkinson's disease, has not received rotigotine within 28 days prior to the baseline visit and is willing to participate in questionnaire based assessments
boolean
C0030567 (UMLS CUI [1])
C1700683 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C0034394 (UMLS CUI [3,2])
Levodopa | Combined Modality Therapy | Dopamine Agonists | Exception Rotigotine
Item
the patient is receiving l-dopa as monotherapy or a combination therapy composed of l-dopa and a dopamine agonist other than rotigotine
boolean
C0023570 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0178601 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1700683 (UMLS CUI [4,2])
Levodopa | Disease Response
Item
the patient has been on l-dopa therapy for at least 6 months and is responding to initial l-dopa therapy
boolean
C0023570 (UMLS CUI [1])
C1704632 (UMLS CUI [2])
MDS-UPDRS - Hoehn and Yahr Stage
Item
the patient has a hoehn and yahr stage score of 1 to 4.
boolean
C3639483 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
patients will be excluded from the study if they have participated in a clinical study of a medication or a medical device within 3 months prior to baseline or if they are participating in a clinical study at the time of inclusion or have already participated in the current study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
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