ID

31345

Description

Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).; ODM derived from: https://clinicaltrials.gov/show/NCT00601523

Lien

https://clinicaltrials.gov/show/NCT00601523

Mots-clés

Versions (1)
  1. 16/08/2018 16/08/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

16 août 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Parkinson Disease NCT00601523

Anglais

Eligibility Parkinson Disease NCT00601523

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. completion of the double-blind trial 248.524 or 248.636
Description

Completion of clinical trial Double-Blind Method

Type de données

boolean

Alias
UMLS CUI [1,1]
C2732579
UMLS CUI [1,2]
C0013072
2. male or female patient with early idiopathic parkinson´s disease (pd), and with a modified hoehn and yahr stage of i to iii.
Description

Parkinson Disease Early Modified Hoehn and Yahr Staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C1279919
UMLS CUI [1,3]
C3639878
3. patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Description

Protocol Compliance

Type de données

boolean

Alias
UMLS CUI [1]
C0525058
4. signed informed consent obtained before any study procedures are carried out (in accordance with international conference on harmonisation (ich) - good clinical practice (gcp) guidelines and local legislation).
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
Description

Patient withdrawn from trial Double-Blind Method

Type de données

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0013072
2. atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or degenerative diseases.
Description

Parkinsonian Disorders Atypical Drug-induced | Parkinsonian Disorders Atypical Due to Metabolic Diseases | Parkinsonian Disorders Atypical Due to Encephalitis | Parkinsonian Disorders Atypical Due to Degenerative disorder

Type de données

boolean

Alias
UMLS CUI [1,1]
C0242422
UMLS CUI [1,2]
C0205182
UMLS CUI [1,3]
C0458082
UMLS CUI [2,1]
C0242422
UMLS CUI [2,2]
C0205182
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0025517
UMLS CUI [3,1]
C0242422
UMLS CUI [3,2]
C0205182
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0014038
UMLS CUI [4,1]
C0242422
UMLS CUI [4,2]
C0205182
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C1285162
3. any psychiatric disorder according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.4.history of psychosis, except history of drug induced hallucinations.
Description

Mental disorders Preventing Compliance behavior | Mental disorders Preventing Completion of clinical trial | Mental disorders Study Subject Participation Status At risk | Psychotic Disorders | Exception Drug-induced hallucinations

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1321605
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C2732579
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4]
C0033975
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1456732
5. clinically significant electrocardiogram (ecg) abnormalities at baseline. 6.clinically significant hypotension 7.malignant melanoma or history of previously treated malignant melanoma. 8.any other clinically significant disease, that could put the patient at risk or could prevent compliance or completion of the study. 9. pregnancy or breast-feeding.
Description

Electrocardiogram abnormal | Hypotension | Melanoma | Melanoma Treated | Disease At risk Patient | Disease Preventing Compliance behavior | Disease Preventing Completion of clinical trial | Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0020649
UMLS CUI [3]
C0025202
UMLS CUI [4,1]
C0025202
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C1444641
UMLS CUI [5,3]
C0030705
UMLS CUI [6,1]
C0012634
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C1321605
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C1292733
UMLS CUI [7,3]
C2732579
UMLS CUI [8]
C0032961
UMLS CUI [9]
C0006147
10. sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study.11 serum levels of aspartate aminotransferase (ast) (sgot), alanine aminotransferase (alt) (sgpt), alkaline phosphatase or bilirubin > 2 upper limit of normal (uln) at baseline 12. patients with a creatinine clearance < 50 ml/min (estimated by the cockcroft and gault formula). 13. motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.
Description

Gender Sexually active | Childbearing Potential Contraceptive methods Absent | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Serum bilirubin increased | Estimation of creatinine clearance by Cockcroft-Gault formula | Motor Complication | Relationship Levodopa | On - off phenomenon | Dyskinetic syndrome

Type de données

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151849
UMLS CUI [6]
C0859062
UMLS CUI [7]
C2711451
UMLS CUI [8,1]
C0009566
UMLS CUI [8,2]
C0501384
UMLS CUI [9,1]
C0439849
UMLS CUI [9,2]
C0023570
UMLS CUI [10]
C0852903
UMLS CUI [11]
C0013384
14. any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit. 15.any of the following drugs within 4 weeks prior to baseline: methylphenidate, cinnarizine, amphetamines. 16. flunarizine within 3 months prior to baseline.
Description

Dopamine Antagonists | Dopamine Antagonists Formulation Intramuscular | Methylphenidate | Cinnarizine | Amphetamines | Flunarizine

Type de données

boolean

Alias
UMLS CUI [1]
C0242702
UMLS CUI [2,1]
C0242702
UMLS CUI [2,2]
C0524527
UMLS CUI [2,3]
C0442117
UMLS CUI [3]
C0025810
UMLS CUI [4]
C0008803
UMLS CUI [5]
C0002667
UMLS CUI [6]
C0016295
17. known hypersensitivity to pramipexole or its excipients. 18. drug abuse (including alcohol), according to investigator´s judgement, within 2 years prior to baseline.
Description

Hypersensitivity Pramipexole | Hypersensitivity Pramipexole Excipient | Substance Use Disorders

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0074710
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0074710
UMLS CUI [2,3]
C0015237
UMLS CUI [3]
C0038586
19. participation in investigational drug studies other than trials 248.524 and 248.636 or use of other investigational drug within one month or five times the half-life of the investigational drug prior to baseline.
Description

Study Subject Participation Status | Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Parkinson Disease NCT00601523

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Completion of clinical trial Double-Blind Method
Item
1. completion of the double-blind trial 248.524 or 248.636
boolean
C2732579 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
Parkinson Disease Early Modified Hoehn and Yahr Staging
Item
2. male or female patient with early idiopathic parkinson´s disease (pd), and with a modified hoehn and yahr stage of i to iii.
boolean
C0030567 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C3639878 (UMLS CUI [1,3])
Protocol Compliance
Item
3. patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
4. signed informed consent obtained before any study procedures are carried out (in accordance with international conference on harmonisation (ich) - good clinical practice (gcp) guidelines and local legislation).
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patient withdrawn from trial Double-Blind Method
Item
1. patients prematurely withdrawn from the double-blind trials 248.524 or 248.636.
boolean
C0422727 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
Parkinsonian Disorders Atypical Drug-induced | Parkinsonian Disorders Atypical Due to Metabolic Diseases | Parkinsonian Disorders Atypical Due to Encephalitis | Parkinsonian Disorders Atypical Due to Degenerative disorder
Item
2. atypical parkinsonian syndromes due to drugs,metabolic disorders, encephalitis or degenerative diseases.
boolean
C0242422 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
C0458082 (UMLS CUI [1,3])
C0242422 (UMLS CUI [2,1])
C0205182 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0025517 (UMLS CUI [2,4])
C0242422 (UMLS CUI [3,1])
C0205182 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0014038 (UMLS CUI [3,4])
C0242422 (UMLS CUI [4,1])
C0205182 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C1285162 (UMLS CUI [4,4])
Mental disorders Preventing Compliance behavior | Mental disorders Preventing Completion of clinical trial | Mental disorders Study Subject Participation Status At risk | Psychotic Disorders | Exception Drug-induced hallucinations
Item
3. any psychiatric disorder according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study.4.history of psychosis, except history of drug induced hallucinations.
boolean
C0004936 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0033975 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C1456732 (UMLS CUI [5,2])
Electrocardiogram abnormal | Hypotension | Melanoma | Melanoma Treated | Disease At risk Patient | Disease Preventing Compliance behavior | Disease Preventing Completion of clinical trial | Pregnancy | Breast Feeding
Item
5. clinically significant electrocardiogram (ecg) abnormalities at baseline. 6.clinically significant hypotension 7.malignant melanoma or history of previously treated malignant melanoma. 8.any other clinically significant disease, that could put the patient at risk or could prevent compliance or completion of the study. 9. pregnancy or breast-feeding.
boolean
C0522055 (UMLS CUI [1])
C0020649 (UMLS CUI [2])
C0025202 (UMLS CUI [3])
C0025202 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C0030705 (UMLS CUI [5,3])
C0012634 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C1321605 (UMLS CUI [6,3])
C0012634 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C2732579 (UMLS CUI [7,3])
C0032961 (UMLS CUI [8])
C0006147 (UMLS CUI [9])
Gender Sexually active | Childbearing Potential Contraceptive methods Absent | Aspartate aminotransferase increased | Alanine aminotransferase increased | Alkaline phosphatase raised | Serum bilirubin increased | Estimation of creatinine clearance by Cockcroft-Gault formula | Motor Complication | Relationship Levodopa | On - off phenomenon | Dyskinetic syndrome
Item
10. sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study.11 serum levels of aspartate aminotransferase (ast) (sgot), alanine aminotransferase (alt) (sgpt), alkaline phosphatase or bilirubin > 2 upper limit of normal (uln) at baseline 12. patients with a creatinine clearance < 50 ml/min (estimated by the cockcroft and gault formula). 13. motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
C0859062 (UMLS CUI [6])
C2711451 (UMLS CUI [7])
C0009566 (UMLS CUI [8,1])
C0501384 (UMLS CUI [8,2])
C0439849 (UMLS CUI [9,1])
C0023570 (UMLS CUI [9,2])
C0852903 (UMLS CUI [10])
C0013384 (UMLS CUI [11])
Dopamine Antagonists | Dopamine Antagonists Formulation Intramuscular | Methylphenidate | Cinnarizine | Amphetamines | Flunarizine
Item
14. any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit. 15.any of the following drugs within 4 weeks prior to baseline: methylphenidate, cinnarizine, amphetamines. 16. flunarizine within 3 months prior to baseline.
boolean
C0242702 (UMLS CUI [1])
C0242702 (UMLS CUI [2,1])
C0524527 (UMLS CUI [2,2])
C0442117 (UMLS CUI [2,3])
C0025810 (UMLS CUI [3])
C0008803 (UMLS CUI [4])
C0002667 (UMLS CUI [5])
C0016295 (UMLS CUI [6])
Hypersensitivity Pramipexole | Hypersensitivity Pramipexole Excipient | Substance Use Disorders
Item
17. known hypersensitivity to pramipexole or its excipients. 18. drug abuse (including alcohol), according to investigator´s judgement, within 2 years prior to baseline.
boolean
C0020517 (UMLS CUI [1,1])
C0074710 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0074710 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C0038586 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs
Item
19. participation in investigational drug studies other than trials 248.524 and 248.636 or use of other investigational drug within one month or five times the half-life of the investigational drug prior to baseline.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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