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ID

31396

Description

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

Lien

https://clinicaltrials.gov/show/NCT01028586

Mots-clés

Versions (1)
  1. 19/08/2018 19/08/2018 -
Détendeur de droits

see clinicaltrials.gov

Téléchargé le

19 août 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Idiopathic Parkinson's Disease NCT01028586

    Anglais

    Eligibility Idiopathic Parkinson's Disease NCT01028586

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

    Completion of clinical trial

    Type de données

    boolean

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

    Clinical Trials; Requirement; Complete

    Type de données

    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".
    Description

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

    Type de données

    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
    Description

    Informed Consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    Pregnancy | Breast Feeding

    Type de données

    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.
    Description

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

    Type de données

    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.
    Description

    Deterioration of status; Significant; Time

    Type de données

    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.
    Description

    Motor deterioration; Time | Antiparkinson Agents; Titration Method

    Type de données

    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
    Description

    Conflict of Interest

    Type de données

    boolean

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

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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3700367
    UMLS CUI [1,2]
    C0037088
    UMLS CUI [1,3]
    C0332299
    Retour au début de la page

    Similar models

    Eligibility Idiopathic Parkinson's Disease NCT01028586

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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