ID

22378

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT00368108

Keywords

versioni (3)
  1. 01/06/17 01/06/17 -
  2. 01/06/17 01/06/17 -
  3. 01/06/17 01/06/17 -
Caricato su

1 giugno 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Eligibility Parkinson's Disease NCT00368108

Inglese

Eligibility Parkinson's Disease NCT00368108

1 moduli  
Inclusion Criteria
Descrizione

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.
Descrizione

Gender | Parkinson Disease | Levodopa | Good therapeutic response

Tipo di dati

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.
Descrizione

Parkinson Disease | Age

Tipo di dati

boolean

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

Motor fluctuations | Wearing off effect

Tipo di dati

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.
Descrizione

Hoehn and Yahr Stage | Wearing off effect

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3639483
UMLS CUI [2]
C1504539
5. patients must be taking optimized levodopa therapy.
Descrizione

Levodopa | Optimization of medication

Tipo di dati

boolean

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

Exclusion Criteria

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

Pregnancy | Breast Feeding

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Substance Use Disorders

Tipo di dati

boolean

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

Feeling suicidal | Suicide attempt

Tipo di dati

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.
Descrizione

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

Tipo di dati

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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 | Wearing off effect
Item
4. patients must rate between ii-iv on the hoehn & yahr scale when in an "off" state.
boolean
C3639483 (UMLS CUI [1])
C1504539 (UMLS CUI [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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