ID

22391

Beskrivning

Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations; ODM derived from: https://clinicaltrials.gov/show/NCT00368108

Länk

https://clinicaltrials.gov/show/NCT00368108

Nyckelord

Versioner (3)
  1. 2017-06-01 2017-06-01 -
  2. 2017-06-01 2017-06-01 -
  3. 2017-06-01 2017-06-01 -
Uppladdad den

1 juni 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00368108

Engelsk

Eligibility Parkinson's Disease NCT00368108

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients with idiopathic parkinson's disease fulfilling the united kingdom (uk) parkinson's disease society brain bank diagnostic criteria 7, with a good response to levodopa.
Beskrivning

Gender | Parkinson Disease | Levodopa | Good therapeutic response

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0030567
UMLS CUI [3]
C0023570
UMLS CUI [4]
C0184785
2. patients must have been diagnosed with idiopathic pd at > 30 years of age.
Beskrivning

Parkinson Disease | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2]
C0001779
3. patients must have predictable motor fluctuations of the wearing "off" type.
Beskrivning

Motor fluctuations | Wearing off effect

Datatyp

boolean

Alias
UMLS CUI [1]
C1868976
UMLS CUI [2]
C1504539
4. patients must rate between ii-iv on the hoehn & yahr scale when in an "off" state.
Beskrivning

Hoehn and Yahr Stage | Pharmaceutical Preparations Off

Datatyp

boolean

Alias
UMLS CUI [1]
C3639483
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1518543
5. patients must be taking optimized levodopa therapy.
Beskrivning

Levodopa | Optimization of medication

Datatyp

boolean

Alias
UMLS CUI [1]
C0023570
UMLS CUI [2]
C4075704
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating women.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). these patients must have a negative serum beta-human chorionic gonadotrophin (b-hcg) test at the screening visit, and a negative urine pregnancy test at the baseline visit (day 0). these patients must also be willing to remain on their current form of contraception for the duration of the study. postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the investigator.
Beskrivning

Childbearing Potential Contraceptive methods | Infertility | Female Sterilization | Sexual Abstinence | Intrauterine Devices | Contraception, Barrier | Hormonal contraception | Serum pregnancy test (B-HCG) Negative | Urine pregnancy test negative | Postmenopausal state | Amenorrhea

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0021359
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0036899
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0004764
UMLS CUI [7]
C2985296
UMLS CUI [8,1]
C0430060
UMLS CUI [8,2]
C1513916
UMLS CUI [9]
C0430057
UMLS CUI [10]
C0232970
UMLS CUI [11]
C0002453
3. patients with a past or present history of drug or alcohol abuse as per diagnostic and statistical manual - 4th edition (dsm iv) criteria.
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
4. patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
Beskrivning

Feeling suicidal | Suicide attempt

Datatyp

boolean

Alias
UMLS CUI [1]
C0424000
UMLS CUI [2]
C0038663
5. patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
Beskrivning

Abnormality Unstable Complicating Investigational New Drugs Assessment | Liver diseases | Kidney Diseases | Cardiovascular Diseases | Respiration Disorders | Gastrointestinal Diseases | Hematological Disease | Endocrine System Diseases | Metabolic Diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0231242
UMLS CUI [1,4]
C0013230
UMLS CUI [1,5]
C1516048
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0018939
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0025517
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Similar models

Eligibility Parkinson's Disease NCT00368108

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Parkinson Disease | Levodopa | Good therapeutic response
Item
1. male or female patients with idiopathic parkinson's disease fulfilling the united kingdom (uk) parkinson's disease society brain bank diagnostic criteria 7, with a good response to levodopa.
boolean
C0079399 (UMLS CUI [1])
C0030567 (UMLS CUI [2])
C0023570 (UMLS CUI [3])
C0184785 (UMLS CUI [4])
Parkinson Disease | Age
Item
2. patients must have been diagnosed with idiopathic pd at > 30 years of age.
boolean
C0030567 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Motor fluctuations | Wearing off effect
Item
3. patients must have predictable motor fluctuations of the wearing "off" type.
boolean
C1868976 (UMLS CUI [1])
C1504539 (UMLS CUI [2])
Hoehn and Yahr Stage | Pharmaceutical Preparations Off
Item
4. patients must rate between ii-iv on the hoehn & yahr scale when in an "off" state.
boolean
C3639483 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C1518543 (UMLS CUI [2,2])
Levodopa | Optimization of medication
Item
5. patients must be taking optimized levodopa therapy.
boolean
C0023570 (UMLS CUI [1])
C4075704 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Infertility | Female Sterilization | Sexual Abstinence | Intrauterine Devices | Contraception, Barrier | Hormonal contraception | Serum pregnancy test (B-HCG) Negative | Urine pregnancy test negative | Postmenopausal state | Amenorrhea
Item
2. women of child bearing potential unless infertile (including surgically sterile) or practicing effective contraception (eg, abstinence, intrauterine device or barrier method plus hormonal method). these patients must have a negative serum beta-human chorionic gonadotrophin (b-hcg) test at the screening visit, and a negative urine pregnancy test at the baseline visit (day 0). these patients must also be willing to remain on their current form of contraception for the duration of the study. postmenopausal women may be recruited but must be amenorrheic for at least one year to be considered of non-child bearing potential as determined by the investigator.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0021359 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C2985296 (UMLS CUI [7])
C0430060 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C0430057 (UMLS CUI [9])
C0232970 (UMLS CUI [10])
C0002453 (UMLS CUI [11])
Substance Use Disorders
Item
3. patients with a past or present history of drug or alcohol abuse as per diagnostic and statistical manual - 4th edition (dsm iv) criteria.
boolean
C0038586 (UMLS CUI [1])
Feeling suicidal | Suicide attempt
Item
4. patients with a past (within one year) or present history of suicidal ideation or suicide attempts.
boolean
C0424000 (UMLS CUI [1])
C0038663 (UMLS CUI [2])
Abnormality Unstable Complicating Investigational New Drugs Assessment | Liver diseases | Kidney Diseases | Cardiovascular Diseases | Respiration Disorders | Gastrointestinal Diseases | Hematological Disease | Endocrine System Diseases | Metabolic Diseases
Item
5. patients with unstable abnormalities of the hepatic, renal, cardiovascular, respiratory, gastro-intestinal, hematological, endocrine or metabolic systems which might complicate assessment of the tolerability of the study medication.
boolean
C1704258 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0231242 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C1516048 (UMLS CUI [1,5])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0018939 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
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