ID

36800

Beschreibung

Study on Tolerability of Repeat i.c.v. Administration of sNN0031 Infusion Solution in Patients With PD; ODM derived from: https://clinicaltrials.gov/show/NCT02408562

Link

https://clinicaltrials.gov/show/NCT02408562

Stichworte

Versionen (1)
  1. 11.06.19 11.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. Juni 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02408562

Englisch

Eligibility Parkinson's Disease NCT02408562

1 Formulare  
Criteria
Beschreibung

Criteria

1. disease duration ≥ 5 years (diagnosis based on medical history and neurological examination).
Beschreibung

Disease length

Datentyp

boolean

Alias
UMLS CUI [1]
C0872146
2. male or female, age 30 - 75 years inclusive.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. motor fluctuations, with off-time >1.5 hours during the day
Beschreibung

Motor fluctuations

Datentyp

boolean

Alias
UMLS CUI [1]
C1868976
4. a hoehn and yahr stage of 2 to 4 during off phase
Beschreibung

Hoehn and Yahr Stage

Datentyp

boolean

Alias
UMLS CUI [1]
C3639483
5. score >22 on the updrs part iii during on phase
Beschreibung

UPDRS

Datentyp

boolean

Alias
UMLS CUI [1]
C3639721
6. patients should be l-dopa responsive and demonstrate at least a 30% decrease in the updrs part iii score after administration of l-dopa (l-dopa challenge test)
Beschreibung

Levodopa-responsive | UPDRS Decrease Percentage | Status post Levodopa Challenge test

Datentyp

boolean

Alias
UMLS CUI [1]
C1853846
UMLS CUI [2,1]
C3639721
UMLS CUI [2,2]
C0547047
UMLS CUI [2,3]
C0439165
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0023570
UMLS CUI [3,3]
C1315011
7. optimised and stable anti-parkinson treatment for at least 3 months before screening
Beschreibung

Antiparkinson Agents Optimal Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003405
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0205360
main exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
1. the patient has any indication of forms of parkinsonism other than idiopathic parkinson's disease
Beschreibung

Indication Parkinsonian Disorders | Exception Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0242422
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0030567
2. the patient is in a late stage of parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms
Beschreibung

Parkinson Disease Late stage | Peak Dose Severely disabling | Dyskinetic syndrome Biphasic | Fluctuations Symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C0544467
UMLS CUI [2,1]
C0444505
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C4035398
UMLS CUI [3,1]
C0013384
UMLS CUI [3,2]
C0205184
UMLS CUI [4,1]
C0231239
UMLS CUI [4,2]
C1457887
3. patients who are on treatment with duodopa or apomorphine pump at the time of screening
Beschreibung

On pump Duodopa | On pump Apomorphine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3842462
UMLS CUI [1,2]
C3489433
UMLS CUI [2,1]
C3842462
UMLS CUI [2,2]
C0003596
4. the patient has an implanted shunt for the drainage of csf or an implanted central nervous system (cns) catheter, or have received neurosurgical intervention related to pd (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the trial period
Beschreibung

Shunt Implanted Drainage of cerebrospinal fluid | Central Nervous System Catheter Implanted | Neurosurgical Procedures Relationship Parkinson Disease | Deep Brain Stimulation | Thalamotomy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0542331
UMLS CUI [1,2]
C0021102
UMLS CUI [1,3]
C2609090
UMLS CUI [2,1]
C3714787
UMLS CUI [2,2]
C0085590
UMLS CUI [2,3]
C0021102
UMLS CUI [3,1]
C0524850
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0030567
UMLS CUI [4]
C0394162
UMLS CUI [5]
C0195894
5. concurrent diagnoses of dementia with a score of 24 or lower on mini-mental state examination (mmse).
Beschreibung

Dementia Mini-mental state examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0451306
6. the patient is depressed, as indicated by a hamilton depression rating scale (grid-hamd, 17-item scale) score > 17
Beschreibung

Depressed Hamilton Depression Rating Scale 17 Item Clinical Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344315
UMLS CUI [1,2]
C3639712
7. patients who are at high risk of suicide as judged by the rating of the columbia symptoms suicide rating scale (c-ssrs)
Beschreibung

High suicide risk Columbia suicide severity rating scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1271074
UMLS CUI [1,2]
C3888485
8. patients with a history of increased intracranial pressure
Beschreibung

Intracranial Hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0151740
9. ophthalmologic examination (funduscopy and visual acuity by early treatment of diabetic retinopathy study (edtrs) and perimetry) with clinically significant findings that imply safety concerns for this study
Beschreibung

Ophthalmologic examination | Ophthalmoscopy | Early Treatment of Diabetic Retinopathy Study Eye Chart | Perimetry | Finding Clinical Significance | Safety Concerns Clinical Trial

Datentyp

boolean

Alias
UMLS CUI [1]
C0200149
UMLS CUI [2]
C0029090
UMLS CUI [3]
C3899277
UMLS CUI [4]
C0031061
UMLS CUI [5,1]
C0243095
UMLS CUI [5,2]
C2826293
UMLS CUI [6,1]
C0036043
UMLS CUI [6,2]
C2699424
UMLS CUI [6,3]
C0008976
10. the patient has a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease
Beschreibung

Gastrointestinal Disease | Kidney Disease | Liver disease | Endocrine System Disease | Lung disease | Cardiovascular Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0014130
UMLS CUI [5]
C0024115
UMLS CUI [6]
C0007222
11. the patient has heart problems or a significant ecg abnormality
Beschreibung

HEART PROBLEM | ECG abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0795691
UMLS CUI [2]
C0522055
12. uncontrolled hypertension.
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
13. the patient has in the past experienced psychotic symptoms (e.g. schizophrenia or psychotic depression)
Beschreibung

Psychotic symptom | Schizophrenia | Depression, psychotic

Datentyp

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2]
C0036341
UMLS CUI [3]
C0743072
14. the patient has a mental or physical condition which would preclude performing study assessments
Beschreibung

Mental condition Excludes Assessment | Physical Condition Excludes Assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3840291
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1516048
UMLS CUI [2,1]
C3714565
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C1516048
15. alcohol or substance dependence within the prior 12 months, or abuse within 3 months, with the exceptions of nicotine
Beschreibung

Substance Dependence | Substance Use Disorders | Exception Nicotine Dependence | Exception Nicotine abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0038586
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028043
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2363943
16. mri examination with findings of tumours or potential sources of pathological bleedings, or any abnormality that may put the patient at risk
Beschreibung

Neoplasms MRI | Source Hemorrhage MRI | Abnormality At risk Patient MRI

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C0449416
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0030705
UMLS CUI [3,4]
C0024485
17. history of structural brain disease including tumours and hyperplasia
Beschreibung

Structural brain disorders | Brain Neoplasms | Hyperplasia Brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0851391
UMLS CUI [2]
C0006118
UMLS CUI [3,1]
C0020507
UMLS CUI [3,2]
C0006104
18. ongoing or suspected primary or recurrent malignant disease (currently active or in remission for less than one year)
Beschreibung

Primary tumor | Recurrent tumor | Primary tumor Suspected | Recurrent tumor Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C0677930
UMLS CUI [2]
C0521158
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0521158
UMLS CUI [4,2]
C0750491
19. any disorder that precludes a surgical procedure, alters wound healing or renders chronic i.c.v. delivery or device implants medically unsuitable
Beschreibung

Disease Excludes Operative Surgical Procedures | Disease Changing Wound Healing | Implants Inappropriate

Datentyp

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
UMLS CUI [3,1]
C0021102
UMLS CUI [3,2]
C1548788
20. the patient has a history or a current diagnosis of hiv, hepatitis b or c.
Beschreibung

HIV Infection | Hepatitis B | Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
21. increased susceptibility to infections
Beschreibung

Susceptibility to infections Increased

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521978
UMLS CUI [1,2]
C0205217
22. women who are pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0558080
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Ähnliche Modelle

Eligibility Parkinson's Disease NCT02408562

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Disease length
Item
1. disease duration ≥ 5 years (diagnosis based on medical history and neurological examination).
boolean
C0872146 (UMLS CUI [1])
Age
Item
2. male or female, age 30 - 75 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Motor fluctuations
Item
3. motor fluctuations, with off-time >1.5 hours during the day
boolean
C1868976 (UMLS CUI [1])
Hoehn and Yahr Stage
Item
4. a hoehn and yahr stage of 2 to 4 during off phase
boolean
C3639483 (UMLS CUI [1])
UPDRS
Item
5. score >22 on the updrs part iii during on phase
boolean
C3639721 (UMLS CUI [1])
Levodopa-responsive | UPDRS Decrease Percentage | Status post Levodopa Challenge test
Item
6. patients should be l-dopa responsive and demonstrate at least a 30% decrease in the updrs part iii score after administration of l-dopa (l-dopa challenge test)
boolean
C1853846 (UMLS CUI [1])
C3639721 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0023570 (UMLS CUI [3,2])
C1315011 (UMLS CUI [3,3])
Antiparkinson Agents Optimal Stable
Item
7. optimised and stable anti-parkinson treatment for at least 3 months before screening
boolean
C0003405 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Indication Parkinsonian Disorders | Exception Parkinson Disease
Item
1. the patient has any indication of forms of parkinsonism other than idiopathic parkinson's disease
boolean
C3146298 (UMLS CUI [1,1])
C0242422 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0030567 (UMLS CUI [2,2])
Parkinson Disease Late stage | Peak Dose Severely disabling | Dyskinetic syndrome Biphasic | Fluctuations Symptoms
Item
2. the patient is in a late stage of parkinson's disease, and is experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms
boolean
C0030567 (UMLS CUI [1,1])
C0544467 (UMLS CUI [1,2])
C0444505 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C4035398 (UMLS CUI [2,3])
C0013384 (UMLS CUI [3,1])
C0205184 (UMLS CUI [3,2])
C0231239 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
On pump Duodopa | On pump Apomorphine
Item
3. patients who are on treatment with duodopa or apomorphine pump at the time of screening
boolean
C3842462 (UMLS CUI [1,1])
C3489433 (UMLS CUI [1,2])
C3842462 (UMLS CUI [2,1])
C0003596 (UMLS CUI [2,2])
Shunt Implanted Drainage of cerebrospinal fluid | Central Nervous System Catheter Implanted | Neurosurgical Procedures Relationship Parkinson Disease | Deep Brain Stimulation | Thalamotomy
Item
4. the patient has an implanted shunt for the drainage of csf or an implanted central nervous system (cns) catheter, or have received neurosurgical intervention related to pd (e.g. deep brain stimulation, thalamotomy etc.) or is scheduled to do so during the trial period
boolean
C0542331 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C2609090 (UMLS CUI [1,3])
C3714787 (UMLS CUI [2,1])
C0085590 (UMLS CUI [2,2])
C0021102 (UMLS CUI [2,3])
C0524850 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0030567 (UMLS CUI [3,3])
C0394162 (UMLS CUI [4])
C0195894 (UMLS CUI [5])
Dementia Mini-mental state examination
Item
5. concurrent diagnoses of dementia with a score of 24 or lower on mini-mental state examination (mmse).
boolean
C0497327 (UMLS CUI [1,1])
C0451306 (UMLS CUI [1,2])
Depressed Hamilton Depression Rating Scale 17 Item Clinical Classification
Item
6. the patient is depressed, as indicated by a hamilton depression rating scale (grid-hamd, 17-item scale) score > 17
boolean
C0344315 (UMLS CUI [1,1])
C3639712 (UMLS CUI [1,2])
High suicide risk Columbia suicide severity rating scale
Item
7. patients who are at high risk of suicide as judged by the rating of the columbia symptoms suicide rating scale (c-ssrs)
boolean
C1271074 (UMLS CUI [1,1])
C3888485 (UMLS CUI [1,2])
Intracranial Hypertension
Item
8. patients with a history of increased intracranial pressure
boolean
C0151740 (UMLS CUI [1])
Ophthalmologic examination | Ophthalmoscopy | Early Treatment of Diabetic Retinopathy Study Eye Chart | Perimetry | Finding Clinical Significance | Safety Concerns Clinical Trial
Item
9. ophthalmologic examination (funduscopy and visual acuity by early treatment of diabetic retinopathy study (edtrs) and perimetry) with clinically significant findings that imply safety concerns for this study
boolean
C0200149 (UMLS CUI [1])
C0029090 (UMLS CUI [2])
C3899277 (UMLS CUI [3])
C0031061 (UMLS CUI [4])
C0243095 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
C0036043 (UMLS CUI [6,1])
C2699424 (UMLS CUI [6,2])
C0008976 (UMLS CUI [6,3])
Gastrointestinal Disease | Kidney Disease | Liver disease | Endocrine System Disease | Lung disease | Cardiovascular Disease
Item
10. the patient has a current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease
boolean
C0017178 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0014130 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
C0007222 (UMLS CUI [6])
HEART PROBLEM | ECG abnormal
Item
11. the patient has heart problems or a significant ecg abnormality
boolean
C0795691 (UMLS CUI [1])
C0522055 (UMLS CUI [2])
Uncontrolled hypertension
Item
12. uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
Psychotic symptom | Schizophrenia | Depression, psychotic
Item
13. the patient has in the past experienced psychotic symptoms (e.g. schizophrenia or psychotic depression)
boolean
C0871189 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
C0743072 (UMLS CUI [3])
Mental condition Excludes Assessment | Physical Condition Excludes Assessment
Item
14. the patient has a mental or physical condition which would preclude performing study assessments
boolean
C3840291 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C3714565 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1516048 (UMLS CUI [2,3])
Substance Dependence | Substance Use Disorders | Exception Nicotine Dependence | Exception Nicotine abuse
Item
15. alcohol or substance dependence within the prior 12 months, or abuse within 3 months, with the exceptions of nicotine
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0028043 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2363943 (UMLS CUI [4,2])
Neoplasms MRI | Source Hemorrhage MRI | Abnormality At risk Patient MRI
Item
16. mri examination with findings of tumours or potential sources of pathological bleedings, or any abnormality that may put the patient at risk
boolean
C0027651 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0449416 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
C0024485 (UMLS CUI [3,4])
Structural brain disorders | Brain Neoplasms | Hyperplasia Brain
Item
17. history of structural brain disease including tumours and hyperplasia
boolean
C0851391 (UMLS CUI [1])
C0006118 (UMLS CUI [2])
C0020507 (UMLS CUI [3,1])
C0006104 (UMLS CUI [3,2])
Primary tumor | Recurrent tumor | Primary tumor Suspected | Recurrent tumor Suspected
Item
18. ongoing or suspected primary or recurrent malignant disease (currently active or in remission for less than one year)
boolean
C0677930 (UMLS CUI [1])
C0521158 (UMLS CUI [2])
C0677930 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0521158 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Disease Excludes Operative Surgical Procedures | Disease Changing Wound Healing | Implants Inappropriate
Item
19. any disorder that precludes a surgical procedure, alters wound healing or renders chronic i.c.v. delivery or device implants medically unsuitable
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])
C0021102 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
HIV Infection | Hepatitis B | Hepatitis C
Item
20. the patient has a history or a current diagnosis of hiv, hepatitis b or c.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Susceptibility to infections Increased
Item
21. increased susceptibility to infections
boolean
C0521978 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unwilling
Item
22. women who are pregnant or breast feeding or unwilling to use adequate contraception during the trial (only women of child bearing potential)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
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