ID

22343

Description

Safety of CERE-120 (AAV2-NTN) in Subjects With Idiopathic Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00252850

Lien

https://clinicaltrials.gov/show/NCT00252850

Mots-clés

Versions (1)
  1. 30/05/2017 30/05/2017 -
Téléchargé le

30 mai 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00252850

Anglais

Eligibility Parkinson's Disease NCT00252850

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of bilateral idiopathic parkinson's disease of at least 5 years duration since diagnosis with motor fluctuations, despite adequate oral antiparkinsonian therapy.
Description

Parkinson Disease Bilateral Duration | Motor fluctuations | Antiparkinson Agents Oral

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0449238
UMLS CUI [2]
C1868976
UMLS CUI [3,1]
C0003405
UMLS CUI [3,2]
C1527415
diagnosis of moderate to severe parkinson's disease based on clinical rating scales.
Description

Parkinson Disease MDS-UPDRS - Hoehn and Yahr Stage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C3639483
males or nonpregnant females 35-75 years of age, inclusive.
Description

Gender | Pregnancy Absent | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0001779
stable medication requirements, and clear response to antiparkinsonian medications during the 60-day eligibility evaluation period.
Description

Antiparkinson Agents Stable | Disease Response Clear

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C2963144
no conditions that would render the subject unsuitable for surgery, or that would interfere with any of the assessments of safety or efficacy in this trial.
Description

Patient condition Inappropriate Operative Surgical Procedures | Patient condition Interferes with Evaluation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0683521
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0683521
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0220825
subject's informed consent prior to the performance of any study-specific procedure.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
a history of any clinically significant medical, psychiatric, or laboratory abnormality for which participation in the study would pose a safety risk to the subject.
Description

Abnormality Study Subject Participation Status At risk Patient safety | Laboratory test result abnormal Study Subject Participation Status At risk Patient safety

Type de données

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [2,4]
C1113679
history of treatment of parkinson's disease by any procedure involving intracranial surgery or implantation of a device.
Description

Therapeutic procedure Parkinson Disease | Therapeutic procedure Involving Intracranial surgery | Therapeutic procedure Involving Implants

Type de données

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0745377
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1314939
UMLS CUI [3,3]
C0021102
mri of the brain within 12 months before the anticipated dosing procedure that indicates the presence of an abnormality that may interfere with the assessments of safety or efficacy or would, in the judgment of the investigator, present a surgical risk to the subject.
Description

MRI brain procedure | Abnormality Interferes with Evaluation | Abnormality At risk Operative Surgical Procedures

Type de données

boolean

Alias
UMLS CUI [1]
C0412675
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0220825
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0543467
any disorder that precludes a surgical procedure or alters wound healing.
Description

Disease Excludes Operative Surgical Procedures | Disease Changing Wound Healing

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0043240
a score of less than or equal to 25 on the folstein mini-mental examination performed during the eligibility evaluation period.
Description

mini-mental status exam score

Type de données

boolean

Alias
UMLS CUI [1]
C2225229
chemotherapy, cytotoxic therapy, or immunotherapy within 6 weeks prior to cere-120 administration.
Description

Chemotherapy | Cytotoxic therapy | Immunotherapy | Investigational New Drug

Type de données

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0677881
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0013230
vaccinations within 30 days prior to cere-120 administration.
Description

Vaccination | Investigational New Drug

Type de données

boolean

Alias
UMLS CUI [1]
C0042196
UMLS CUI [2]
C0013230
history, within two years before the anticipated dosing procedure, of drug or alcohol abuse.
Description

Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1]
C0038586
treatment with nonantiparkinsonian agents that may affect symptoms of parkinson's disease within 60 days before the anticipated dosing procedure.
Description

Pharmaceutical Preparations Affecting Symptoms Parkinson Disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0030567
any medical disability that would interfere with the assessment of safety and efficacy in this trial or would compromise the ability of the subject to undergo study procedures (e.g. mri, pet) or to give informed consent.
Description

Disability Interferes with Evaluation | Disability compromises Protocol Compliance | Magnetic Resonance Imaging | Positron-Emission Tomography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0231170
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0220825
UMLS CUI [2,1]
C0231170
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
UMLS CUI [3]
C0024485
UMLS CUI [4]
C0032743
history of prior gene transfer therapy.
Description

Gene Transfer Techniques

Type de données

boolean

Alias
UMLS CUI [1]
C0886519
treatment with an investigational agent within 60 days before the anticipated dosing procedure.
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
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Similar models

Eligibility Parkinson's Disease NCT00252850

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease Bilateral Duration | Motor fluctuations | Antiparkinson Agents Oral
Item
diagnosis of bilateral idiopathic parkinson's disease of at least 5 years duration since diagnosis with motor fluctuations, despite adequate oral antiparkinsonian therapy.
boolean
C0030567 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C1868976 (UMLS CUI [2])
C0003405 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
Parkinson Disease MDS-UPDRS - Hoehn and Yahr Stage
Item
diagnosis of moderate to severe parkinson's disease based on clinical rating scales.
boolean
C0030567 (UMLS CUI [1,1])
C3639483 (UMLS CUI [1,2])
Gender | Pregnancy Absent | Age
Item
males or nonpregnant females 35-75 years of age, inclusive.
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
Antiparkinson Agents Stable | Disease Response Clear
Item
stable medication requirements, and clear response to antiparkinsonian medications during the 60-day eligibility evaluation period.
boolean
C0003405 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C2963144 (UMLS CUI [2,2])
Patient condition Inappropriate Operative Surgical Procedures | Patient condition Interferes with Evaluation
Item
no conditions that would render the subject unsuitable for surgery, or that would interfere with any of the assessments of safety or efficacy in this trial.
boolean
C0683521 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0683521 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])
Informed Consent
Item
subject's informed consent prior to the performance of any study-specific procedure.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Abnormality Study Subject Participation Status At risk Patient safety | Laboratory test result abnormal Study Subject Participation Status At risk Patient safety
Item
a history of any clinically significant medical, psychiatric, or laboratory abnormality for which participation in the study would pose a safety risk to the subject.
boolean
C1704258 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C1113679 (UMLS CUI [2,4])
Therapeutic procedure Parkinson Disease | Therapeutic procedure Involving Intracranial surgery | Therapeutic procedure Involving Implants
Item
history of treatment of parkinson's disease by any procedure involving intracranial surgery or implantation of a device.
boolean
C0087111 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0745377 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1314939 (UMLS CUI [3,2])
C0021102 (UMLS CUI [3,3])
MRI brain procedure | Abnormality Interferes with Evaluation | Abnormality At risk Operative Surgical Procedures
Item
mri of the brain within 12 months before the anticipated dosing procedure that indicates the presence of an abnormality that may interfere with the assessments of safety or efficacy or would, in the judgment of the investigator, present a surgical risk to the subject.
boolean
C0412675 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0220825 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0543467 (UMLS CUI [3,3])
Disease Excludes Operative Surgical Procedures | Disease Changing Wound Healing
Item
any disorder that precludes a surgical procedure or alters wound healing.
boolean
C0012634 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0043240 (UMLS CUI [2,3])
mini-mental status exam score
Item
a score of less than or equal to 25 on the folstein mini-mental examination performed during the eligibility evaluation period.
boolean
C2225229 (UMLS CUI [1])
Chemotherapy | Cytotoxic therapy | Immunotherapy | Investigational New Drug
Item
chemotherapy, cytotoxic therapy, or immunotherapy within 6 weeks prior to cere-120 administration.
boolean
C0392920 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Vaccination | Investigational New Drug
Item
vaccinations within 30 days prior to cere-120 administration.
boolean
C0042196 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Substance Use Disorders
Item
history, within two years before the anticipated dosing procedure, of drug or alcohol abuse.
boolean
C0038586 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Symptoms Parkinson Disease
Item
treatment with nonantiparkinsonian agents that may affect symptoms of parkinson's disease within 60 days before the anticipated dosing procedure.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0030567 (UMLS CUI [1,4])
Disability Interferes with Evaluation | Disability compromises Protocol Compliance | Magnetic Resonance Imaging | Positron-Emission Tomography
Item
any medical disability that would interfere with the assessment of safety and efficacy in this trial or would compromise the ability of the subject to undergo study procedures (e.g. mri, pet) or to give informed consent.
boolean
C0231170 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0231170 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0024485 (UMLS CUI [3])
C0032743 (UMLS CUI [4])
Gene Transfer Techniques
Item
history of prior gene transfer therapy.
boolean
C0886519 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with an investigational agent within 60 days before the anticipated dosing procedure.
boolean
C0013230 (UMLS CUI [1])
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