ID

40364

Beschreibung

Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms; ODM derived from: https://clinicaltrials.gov/show/NCT01300819

Link

https://clinicaltrials.gov/show/NCT01300819

Stichworte

Versionen (1)
  1. 14.04.20 14.04.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. April 2020

DOI

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Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT01300819

Englisch

Eligibility Idiopathic Parkinson's Disease NCT01300819

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is male or female, ≥18 years of age
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subject has idiopathic parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of parkinsonism
Beschreibung

Parkinson Disease | Signs Quantity | Bradykinesia | Resting Tremor | Rigidity | Postural instability

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0233565
UMLS CUI [4]
C0234379
UMLS CUI [5]
C0026837
UMLS CUI [6]
C1843921
subject has a hoehn and yahr stage score ≤4
Beschreibung

Hoehn and Yahr Stage

Datentyp

boolean

Alias
UMLS CUI [1]
C3639483
subject has a total non-motor symptoms scale (nmss) score ≥40
Beschreibung

Symptoms Score | Exception Motor symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0449820
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0426980
if the subject is taking levodopa (l-dopa), he/she must be on a stable dose of l-dopa (in combination with benserazide or carbidopa) for at least 28 days prior to the baseline visit
Beschreibung

Levodopa Dose Stable | Benserazide / Levodopa | Carbidopa / Levodopa

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0358787
UMLS CUI [3]
C0353697
if the subject is receiving anticholinergics, monoamine oxidase (mao) b inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the baseline visit and must be maintained on that dose for the duration of the study
Beschreibung

Anticholinergic Agents Dose Stable | Monoamine Oxidase Inhibitors Dose Stable | Amantadine Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242896
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0026457
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0002403
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator
Beschreibung

Dopamine Agonists Discontinued | Etiology Lack of Efficacy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178601
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0235828
subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the baseline visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-a (mao-a) inhibitors, methylphenidate, amphetamine, or other dopamine agonists (das)
Beschreibung

Pharmacotherapy | Methyldopa | Metoclopramide | Reserpine | Antipsychotic Agents | Exception Antipsychotic Agents Atypical Specific | Exception Olanzapine | Exception Ziprasidone | Exception Aripiprazole | Exception Clozapine | Exception Quetiapine | Monoamine Oxidase Inhibitors | Methylphenidate | Amphetamine | Dopamine Agonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0013216
UMLS CUI [2]
C0025741
UMLS CUI [3]
C0025853
UMLS CUI [4]
C0035179
UMLS CUI [5]
C0040615
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0040615
UMLS CUI [6,3]
C0205182
UMLS CUI [6,4]
C0205369
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0171023
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0380393
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0299792
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0009079
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0123091
UMLS CUI [12]
C0026457
UMLS CUI [13]
C0025810
UMLS CUI [14]
C0002658
UMLS CUI [15]
C0178601
subject is receiving central nervous system (cns) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [ssris], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the baseline visit and is likely to remain stable for the duration of the study
Beschreibung

Central Nervous System Therapy | Sedatives | Hypnotics | Selective Serotonin Reuptake Inhibitors | Anti-Anxiety Agents | Sleep Disorder Agents | Exception Dose Stable Daily

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3714787
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0036557
UMLS CUI [3]
C0020591
UMLS CUI [4]
C0360105
UMLS CUI [5]
C0040616
UMLS CUI [6]
C4020625
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0178602
UMLS CUI [7,3]
C0205360
UMLS CUI [7,4]
C0332173
subject has evidence of an impulse control disorder according to the modified minnesota impulsive disorders interview at the screening visit (visit 1), confirmed by a positive structured clinical interview
Beschreibung

Impulse Control Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0021122
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Ähnliche Modelle

Eligibility Idiopathic Parkinson's Disease NCT01300819

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
subject is male or female, ≥18 years of age
boolean
C0001779 (UMLS CUI [1])
Parkinson Disease | Signs Quantity | Bradykinesia | Resting Tremor | Rigidity | Postural instability
Item
subject has idiopathic parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of parkinsonism
boolean
C0030567 (UMLS CUI [1])
C0311392 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0233565 (UMLS CUI [3])
C0234379 (UMLS CUI [4])
C0026837 (UMLS CUI [5])
C1843921 (UMLS CUI [6])
Hoehn and Yahr Stage
Item
subject has a hoehn and yahr stage score ≤4
boolean
C3639483 (UMLS CUI [1])
Symptoms Score | Exception Motor symptoms
Item
subject has a total non-motor symptoms scale (nmss) score ≥40
boolean
C1457887 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0426980 (UMLS CUI [2,2])
Levodopa Dose Stable | Benserazide / Levodopa | Carbidopa / Levodopa
Item
if the subject is taking levodopa (l-dopa), he/she must be on a stable dose of l-dopa (in combination with benserazide or carbidopa) for at least 28 days prior to the baseline visit
boolean
C0023570 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0358787 (UMLS CUI [2])
C0353697 (UMLS CUI [3])
Anticholinergic Agents Dose Stable | Monoamine Oxidase Inhibitors Dose Stable | Amantadine Dose Stable
Item
if the subject is receiving anticholinergics, monoamine oxidase (mao) b inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the baseline visit and must be maintained on that dose for the duration of the study
boolean
C0242896 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0026457 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0002403 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Dopamine Agonists Discontinued | Etiology Lack of Efficacy
Item
subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator
boolean
C0178601 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0235828 (UMLS CUI [2,2])
Pharmacotherapy | Methyldopa | Metoclopramide | Reserpine | Antipsychotic Agents | Exception Antipsychotic Agents Atypical Specific | Exception Olanzapine | Exception Ziprasidone | Exception Aripiprazole | Exception Clozapine | Exception Quetiapine | Monoamine Oxidase Inhibitors | Methylphenidate | Amphetamine | Dopamine Agonists
Item
subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the baseline visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-a (mao-a) inhibitors, methylphenidate, amphetamine, or other dopamine agonists (das)
boolean
C0013216 (UMLS CUI [1])
C0025741 (UMLS CUI [2])
C0025853 (UMLS CUI [3])
C0035179 (UMLS CUI [4])
C0040615 (UMLS CUI [5])
C1705847 (UMLS CUI [6,1])
C0040615 (UMLS CUI [6,2])
C0205182 (UMLS CUI [6,3])
C0205369 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0171023 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0380393 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0299792 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0009079 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0123091 (UMLS CUI [11,2])
C0026457 (UMLS CUI [12])
C0025810 (UMLS CUI [13])
C0002658 (UMLS CUI [14])
C0178601 (UMLS CUI [15])
Central Nervous System Therapy | Sedatives | Hypnotics | Selective Serotonin Reuptake Inhibitors | Anti-Anxiety Agents | Sleep Disorder Agents | Exception Dose Stable Daily
Item
subject is receiving central nervous system (cns) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [ssris], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the baseline visit and is likely to remain stable for the duration of the study
boolean
C3714787 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0036557 (UMLS CUI [2])
C0020591 (UMLS CUI [3])
C0360105 (UMLS CUI [4])
C0040616 (UMLS CUI [5])
C4020625 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0178602 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C0332173 (UMLS CUI [7,4])
Impulse Control Disorder
Item
subject has evidence of an impulse control disorder according to the modified minnesota impulsive disorders interview at the screening visit (visit 1), confirmed by a positive structured clinical interview
boolean
C0021122 (UMLS CUI [1])
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