ID

31396

Beschrijving

MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918); ODM derived from: https://clinicaltrials.gov/show/NCT01028586

Link

https://clinicaltrials.gov/show/NCT01028586

Trefwoorden

Versies (1)
  1. 19-08-18 19-08-18 -
Houder van rechten

see clinicaltrials.gov

Geüploaded op

19 augustus 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Idiopathic Parkinson's Disease NCT01028586

Engels

Eligibility Idiopathic Parkinson's Disease NCT01028586

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. the subject completed 24 weeks of trial 27918.
Beschrijving

Completion of clinical trial

Datatype

boolean

Alias
UMLS CUI [1]
C2732579
2. the subject successfully completed all trial requirements in trial 27918.
Beschrijving

Clinical Trials; Requirement; Complete

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0205197
3. if female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. for the purposes of this trial, women of childbearing potential are defined as: "all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive".
Beschrijving

Postmenopausal state; Duration (temporal concept) | Female Sterilization | Hysterectomy | Contraceptive methods | Childbearing Potential

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232970
UMLS CUI [1,2]
C0449238
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0020699
UMLS CUI [4,1]
C1960468
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0449238
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0429595
UMLS CUI [5,3]
C0232970
UMLS CUI [5,4]
C0449238
UMLS CUI [5,5]
C0021359
UMLS CUI [5,6]
C0241028
4. subject is willing and able to participate in the trial and has provided written, informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. if female, the subject is pregnant or lactating.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. the subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion.
Beschrijving

Adverse event; Significant; Time | Risk | Clinical Investigators; Opinions

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0040223
UMLS CUI [2]
C0035647
UMLS CUI [3,1]
C0008961
UMLS CUI [3,2]
C0871010
3. the subject has shown clinically significant deterioration during participation in trial 27918.
Beschrijving

Deterioration of status; Significant; Time

Datatype

boolean

Alias
UMLS CUI [1,1]
C1279889
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0040223
4. motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
Beschrijving

Motor deterioration; Time | Antiparkinson Agents; Titration Method

Datatype

boolean

Alias
UMLS CUI [1,1]
C1866284
UMLS CUI [1,2]
C0040223
UMLS CUI [2,1]
C0003405
UMLS CUI [2,2]
C0162621
5. the investigator deems it is not in the subject's best interest to participate to trial 27938
Beschrijving

Conflict of Interest

Datatype

boolean

Alias
UMLS CUI [1]
C0079152
6. signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Beschrijving

Transmissible spongiform encephalopathy | Brain; Signs and Symptoms; Suggestive of Unit

Datatype

boolean

Alias
UMLS CUI [1,1]
C3700367
UMLS CUI [1,2]
C0037088
UMLS CUI [1,3]
C0332299
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Similar models

Eligibility Idiopathic Parkinson's Disease NCT01028586

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Completion of clinical trial
Item
1. the subject completed 24 weeks of trial 27918.
boolean
C2732579 (UMLS CUI [1])
Clinical Trials; Requirement; Complete
Item
2. the subject successfully completed all trial requirements in trial 27918.
boolean
C0008976 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Postmenopausal state; Duration (temporal concept) | Female Sterilization | Hysterectomy | Contraceptive methods | Childbearing Potential
Item
3. if female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. for the purposes of this trial, women of childbearing potential are defined as: "all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive".
boolean
C0232970 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C1960468 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0449238 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C0429595 (UMLS CUI [5,2])
C0232970 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
C0021359 (UMLS CUI [5,5])
C0241028 (UMLS CUI [5,6])
Informed Consent
Item
4. subject is willing and able to participate in the trial and has provided written, informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. if female, the subject is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Adverse event; Significant; Time | Risk | Clinical Investigators; Opinions
Item
2. the subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion.
boolean
C0877248 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0035647 (UMLS CUI [2])
C0008961 (UMLS CUI [3,1])
C0871010 (UMLS CUI [3,2])
Deterioration of status; Significant; Time
Item
3. the subject has shown clinically significant deterioration during participation in trial 27918.
boolean
C1279889 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Motor deterioration; Time | Antiparkinson Agents; Titration Method
Item
4. motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
boolean
C1866284 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0003405 (UMLS CUI [2,1])
C0162621 (UMLS CUI [2,2])
Conflict of Interest
Item
5. the investigator deems it is not in the subject's best interest to participate to trial 27938
boolean
C0079152 (UMLS CUI [1])
Transmissible spongiform encephalopathy | Brain; Signs and Symptoms; Suggestive of Unit
Item
6. signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
boolean
C3700367 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])
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