ID

31454

Beschreibung

A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00880620

Link

https://clinicaltrials.gov/show/NCT00880620

Stichworte

Versionen (1)
  1. 23.08.18 23.08.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

23. August 2018

DOI

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Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00880620

Englisch

Eligibility Parkinson's Disease NCT00880620

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. able to understand and willing to voluntarily sign an informed consent form (icf) and health insurance portability and accountability act (hipaa) authorization or local equivalent if applicable.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. diagnosed with idiopathic pd.
Beschreibung

Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
3. ld-naïve: defined as subjects not exposed to ld or catechol-o-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
Beschreibung

Levodopa naive | Absence Exposure to Levodopa | Absence Exposure to Catechol-O-methyltransferase inhibitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023570
UMLS CUI [1,2]
C0919936
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0023570
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0332157
UMLS CUI [3,3]
C0595267
4. if currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type b (mao-b) inhibitor, maintains a stable regimen for at least 4 weeks prior to baseline, and agrees to maintain the stable regimen throughout study participation.
Beschreibung

Anticholinergic Agents Therapy Stable | Amantadine | MAO-B Inhibitor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242896
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0002403
UMLS CUI [3]
C2917433
5. agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
Beschreibung

Contraceptive methods Agreement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0680240
6. able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
Beschreibung

Protocol Compliance | Patient Available Clinic Visits | Patient Available Telephone call

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C0008952
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0470187
UMLS CUI [3,3]
C0302186
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. diagnosed with atypical parkinsonism or any known secondary parkinsonian syndrome.
Beschreibung

Atypical Parkinsonism | Secondary Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C4302185
UMLS CUI [2]
C0030569
3. prior functional neurosurgical treatment for pd or if such procedures are anticipated during study participation.
Beschreibung

Neurosurgical Procedures Functional Parkinson Disease | Neurosurgical Procedures Anticipated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524850
UMLS CUI [1,2]
C0205245
UMLS CUI [1,3]
C0030567
UMLS CUI [2,1]
C0524850
UMLS CUI [2,2]
C3840775
4. use of nonselective mao inhibitors.
Beschreibung

Monoamine oxidase inhibitors, non-selective

Datentyp

boolean

Alias
UMLS CUI [1]
C3653330
5. use of dopamine agonists within 30 days prior to screening.
Beschreibung

Dopamine Agonists

Datentyp

boolean

Alias
UMLS CUI [1]
C0178601
6. unable to tolerate a placebo regimen, in the investigator's opinion.
Beschreibung

Placebo study Receive Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683952
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
7. treatment of psychosis with any antipsychotic.
Beschreibung

Treatment Psychotic Disorders | Antipsychotic Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0033975
UMLS CUI [2]
C0040615
8. history of seizure or epilepsy.
Beschreibung

Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
9. active or prior medical condition or prior surgical procedure that would interfere with ld absorption.
Beschreibung

Medical condition Interferes with Levodopa Absorption | Operative Surgical Procedure Interferes with Levodopa Absorption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0023570
UMLS CUI [1,4]
C0237442
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0023570
UMLS CUI [2,4]
C0237442
10. history of narrow-angle glaucoma.
Beschreibung

Angle Closure Glaucoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0017605
11. subjects with a history of malignant melanoma.
Beschreibung

Melanoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0025202
12. history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
Beschreibung

Myocardial Infarction | Atrial arrhythmia Residual | Nodal rhythm disorder Residual | Ventricular arrhythmia Residual | Upper gastrointestinal hemorrhage | Neuroleptic Malignant Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0085611
UMLS CUI [2,2]
C1609982
UMLS CUI [3,1]
C0264893
UMLS CUI [3,2]
C1609982
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C1609982
UMLS CUI [5]
C0041909
UMLS CUI [6]
C0027849
13. received any investigational medications during the 30 days prior to screening.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
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Ähnliche Modelle

Eligibility Parkinson's Disease NCT00880620

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. able to understand and willing to voluntarily sign an informed consent form (icf) and health insurance portability and accountability act (hipaa) authorization or local equivalent if applicable.
boolean
C0021430 (UMLS CUI [1])
Parkinson Disease
Item
2. diagnosed with idiopathic pd.
boolean
C0030567 (UMLS CUI [1])
Levodopa naive | Absence Exposure to Levodopa | Absence Exposure to Catechol-O-methyltransferase inhibitor
Item
3. ld-naïve: defined as subjects not exposed to ld or catechol-o-methyl transferase inhibitors for more than 30 days and the exposure is not within 4 weeks prior to study enrollment.
boolean
C0023570 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0023570 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0332157 (UMLS CUI [3,2])
C0595267 (UMLS CUI [3,3])
Anticholinergic Agents Therapy Stable | Amantadine | MAO-B Inhibitor
Item
4. if currently taking anticholinergic therapy, amantadine, or a monoamine oxidase type b (mao-b) inhibitor, maintains a stable regimen for at least 4 weeks prior to baseline, and agrees to maintain the stable regimen throughout study participation.
boolean
C0242896 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0002403 (UMLS CUI [2])
C2917433 (UMLS CUI [3])
Contraceptive methods Agreement
Item
5. agrees to use a medically acceptable method of contraception throughout the study and for 1 month after completing the study.
boolean
C0700589 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
Protocol Compliance | Patient Available Clinic Visits | Patient Available Telephone call
Item
6. able and willing to comply with the protocol, including availability for all scheduled clinic visits and telephone calls.
boolean
C0525058 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C0008952 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
C0302186 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Atypical Parkinsonism | Secondary Parkinson Disease
Item
2. diagnosed with atypical parkinsonism or any known secondary parkinsonian syndrome.
boolean
C4302185 (UMLS CUI [1])
C0030569 (UMLS CUI [2])
Neurosurgical Procedures Functional Parkinson Disease | Neurosurgical Procedures Anticipated
Item
3. prior functional neurosurgical treatment for pd or if such procedures are anticipated during study participation.
boolean
C0524850 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
C0524850 (UMLS CUI [2,1])
C3840775 (UMLS CUI [2,2])
Monoamine oxidase inhibitors, non-selective
Item
4. use of nonselective mao inhibitors.
boolean
C3653330 (UMLS CUI [1])
Dopamine Agonists
Item
5. use of dopamine agonists within 30 days prior to screening.
boolean
C0178601 (UMLS CUI [1])
Placebo study Receive Unable
Item
6. unable to tolerate a placebo regimen, in the investigator's opinion.
boolean
C0683952 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Treatment Psychotic Disorders | Antipsychotic Agents
Item
7. treatment of psychosis with any antipsychotic.
boolean
C0087111 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])
C0040615 (UMLS CUI [2])
Epilepsy
Item
8. history of seizure or epilepsy.
boolean
C0014544 (UMLS CUI [1])
Medical condition Interferes with Levodopa Absorption | Operative Surgical Procedure Interferes with Levodopa Absorption
Item
9. active or prior medical condition or prior surgical procedure that would interfere with ld absorption.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0023570 (UMLS CUI [1,3])
C0237442 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0023570 (UMLS CUI [2,3])
C0237442 (UMLS CUI [2,4])
Angle Closure Glaucoma
Item
10. history of narrow-angle glaucoma.
boolean
C0017605 (UMLS CUI [1])
Melanoma
Item
11. subjects with a history of malignant melanoma.
boolean
C0025202 (UMLS CUI [1])
Myocardial Infarction | Atrial arrhythmia Residual | Nodal rhythm disorder Residual | Ventricular arrhythmia Residual | Upper gastrointestinal hemorrhage | Neuroleptic Malignant Syndrome
Item
12. history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome.
boolean
C0027051 (UMLS CUI [1])
C0085611 (UMLS CUI [2,1])
C1609982 (UMLS CUI [2,2])
C0264893 (UMLS CUI [3,1])
C1609982 (UMLS CUI [3,2])
C0085612 (UMLS CUI [4,1])
C1609982 (UMLS CUI [4,2])
C0041909 (UMLS CUI [5])
C0027849 (UMLS CUI [6])
Investigational New Drugs
Item
13. received any investigational medications during the 30 days prior to screening.
boolean
C0013230 (UMLS CUI [1])
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