ID

32403

Beschreibung

One Year Extension Study To Protocol C2/5/TZ:MS-05; ODM derived from: https://clinicaltrials.gov/show/NCT00464958

Link

https://clinicaltrials.gov/show/NCT00464958

Stichworte

Versionen (1)
  1. 30.10.18 30.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

30. Oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Spasticity NCT00464958

Englisch

Eligibility Spasticity NCT00464958

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Spasticity NCT00464958
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
successful completion of previous protocol, study c2/5/tz:ms-05
Beschreibung

Clinical Trial Specified Completed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C0205197
have a definitive diagnosis of multiple sclerosis
Beschreibung

Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026769
patients may be allowed to take other anti-spasticity medication during the study (other than baclofen pump)as per their individual daily dosing regimen, with the following qualification: (1) no dose after 18:00 on any study day (2) no dose at all on a clinic evaluation day
Beschreibung

Antispasticity Agents Daily Dose | Exception Baclofen pump

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4020576
UMLS CUI [1,2]
C2348070
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C3836732
females must agree to use a medically accepted form of birth control, be surgically sterile, or be two years post-menopausal. oral contraception in not acceptable as it is contraindicated for tizanidine use.
Beschreibung

Gender Contraceptive methods | Female Sterilization | Postmenopausal state | Oral contraception Unacceptable | Oral contraception Contraindicated Tizanidine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0029151
UMLS CUI [4,2]
C1883420
UMLS CUI [5,1]
C0029151
UMLS CUI [5,2]
C1444657
UMLS CUI [5,3]
C0146011
patients must meet criteria for stable 24 hour bp values based on the screening abpm monitorings (with and without tizanidine challenge) as determined by the study's bp consultant
Beschreibung

24 hour blood pressure Stable Ambulatory Blood Pressure Monitoring | Tizanidine Challenge | Tizanidine Challenge Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1282173
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0242876
UMLS CUI [2,1]
C0146011
UMLS CUI [2,2]
C0805586
UMLS CUI [3,1]
C0146011
UMLS CUI [3,2]
C0805586
UMLS CUI [3,3]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of cyp1a2 inhibitors [e.g. ciprofloxacin or fluvoxamine as well as zileuton, other fluroquinolones (norfloxacin), antiarrythmics (amiodarone, mexiletine, propafenone), cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine] from baseline and for the duration of the study
Beschreibung

CYP1A2 Inhibitors | Ciprofloxacin | Fluvoxamine | zileuton | Fluoroquinolones | Norfloxacin | Anti-Arrhythmia Agents | Amiodarone | Mexiletine | Propafenone | Cimetidine | Famotidine | Contraceptives, Oral | Acyclovir | Ticlopidine

Datentyp

boolean

Alias
UMLS CUI [1]
C3850068
UMLS CUI [2]
C0008809
UMLS CUI [3]
C0085228
UMLS CUI [4]
C0081408
UMLS CUI [5]
C0949665
UMLS CUI [6]
C0028365
UMLS CUI [7]
C0003195
UMLS CUI [8]
C0002598
UMLS CUI [9]
C0025887
UMLS CUI [10]
C0033429
UMLS CUI [11]
C0008783
UMLS CUI [12]
C0015620
UMLS CUI [13]
C0009905
UMLS CUI [14]
C0001367
UMLS CUI [15]
C0040207
taking medications from baseline and for the duration of the study that would potentially interfere with the actions of the study medication or outcome variables as determined by the pi
Beschreibung

Pharmaceutical Preparations Interfere with Investigational New Drugs | Pharmaceutical Preparations Interfere with Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0013230
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
previous history of dementia, unstable psychiatric disease or current signs and symptoms of significant medical disorders such as severe, progressive or uncontrolled renal, hepatic hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease
Beschreibung

Dementia | Mental disorders Unstable | Signs and Symptoms Disease Significant | Kidney Diseases Severe | Liver diseases Severe | Hematological Disease Severe | Endocrine System Diseases Severe | Lung diseases Severe | Heart Diseases Severe | Nervous system disorder Severe | Cerebral disorder Severe | Kidney Diseases Progressive | Liver diseases Progressive | Hematological Disease Progressive | Endocrine System Diseases Progressive | Lung diseases Progressive | Heart Diseases Progressive | Nervous system disorder Progressive | Cerebral disorder Progressive | Kidney Diseases Uncontrolled | Liver diseases Uncontrolled | Hematological Disease Uncontrolled | Endocrine System Diseases Uncontrolled | Lung diseases Uncontrolled | Heart Diseases Uncontrolled | Nervous system disorder Uncontrolled | Cerebral disorder Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0443343
UMLS CUI [3,1]
C0037088
UMLS CUI [3,2]
C0012634
UMLS CUI [3,3]
C0750502
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C0023895
UMLS CUI [5,2]
C0205082
UMLS CUI [6,1]
C0018939
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0014130
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0024115
UMLS CUI [8,2]
C0205082
UMLS CUI [9,1]
C0018799
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C0027765
UMLS CUI [10,2]
C0205082
UMLS CUI [11,1]
C0234387
UMLS CUI [11,2]
C0205082
UMLS CUI [12,1]
C0022658
UMLS CUI [12,2]
C0205329
UMLS CUI [13,1]
C0023895
UMLS CUI [13,2]
C0205329
UMLS CUI [14,1]
C0018939
UMLS CUI [14,2]
C0205329
UMLS CUI [15,1]
C0014130
UMLS CUI [15,2]
C0205329
UMLS CUI [16,1]
C0024115
UMLS CUI [16,2]
C0205329
UMLS CUI [17,1]
C0018799
UMLS CUI [17,2]
C0205329
UMLS CUI [18,1]
C0027765
UMLS CUI [18,2]
C0205329
UMLS CUI [19,1]
C0234387
UMLS CUI [19,2]
C0205329
UMLS CUI [20,1]
C0022658
UMLS CUI [20,2]
C0205318
UMLS CUI [21,1]
C0023895
UMLS CUI [21,2]
C0205318
UMLS CUI [22,1]
C0018939
UMLS CUI [22,2]
C0205318
UMLS CUI [23,1]
C0014130
UMLS CUI [23,2]
C0205318
UMLS CUI [24,1]
C0024115
UMLS CUI [24,2]
C0205318
UMLS CUI [25,1]
C0018799
UMLS CUI [25,2]
C0205318
UMLS CUI [26,1]
C0027765
UMLS CUI [26,2]
C0205318
UMLS CUI [27,1]
C0234387
UMLS CUI [27,2]
C0205318
significant abnormalities in screening laboratory parameters as described below:
Beschreibung

Laboratory test result abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0438215
alt > 2xuln
Beschreibung

Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
ast > 2xuln
Beschreibung

Aspartate aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0151904
creatinine > 2.0 mg/dl
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
bilirubin > 2xuln
Beschreibung

Elevated total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0741494
wbc < 2,300/mm3
Beschreibung

White Blood Cell Count procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
platelets < 80,000/mm3
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
history of allergy to tizanidine or any inactive component (including lactose intolerance) of the sublingual tizanidine tablet
Beschreibung

Hypersensitivity Tizanidine | Hypersensitivity Tizanidine Tablet Inactive ingredient | Lactose Intolerance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0146011
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1248220
UMLS CUI [2,3]
C1552019
UMLS CUI [3]
C0022951
history of substance abuse within past 12 months
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
patients who are non-cooperative or unwilling to sign consent form
Beschreibung

Uncooperative behavior | Informed Consent Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0424350
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
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Ähnliche Modelle

Eligibility Spasticity NCT00464958

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Spasticity NCT00464958
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Specified Completed
Item
successful completion of previous protocol, study c2/5/tz:ms-05
boolean
C0008976 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Multiple Sclerosis
Item
have a definitive diagnosis of multiple sclerosis
boolean
C0026769 (UMLS CUI [1])
Antispasticity Agents Daily Dose | Exception Baclofen pump
Item
patients may be allowed to take other anti-spasticity medication during the study (other than baclofen pump)as per their individual daily dosing regimen, with the following qualification: (1) no dose after 18:00 on any study day (2) no dose at all on a clinic evaluation day
boolean
C4020576 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C3836732 (UMLS CUI [2,2])
Gender Contraceptive methods | Female Sterilization | Postmenopausal state | Oral contraception Unacceptable | Oral contraception Contraindicated Tizanidine
Item
females must agree to use a medically accepted form of birth control, be surgically sterile, or be two years post-menopausal. oral contraception in not acceptable as it is contraindicated for tizanidine use.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0029151 (UMLS CUI [4,1])
C1883420 (UMLS CUI [4,2])
C0029151 (UMLS CUI [5,1])
C1444657 (UMLS CUI [5,2])
C0146011 (UMLS CUI [5,3])
24 hour blood pressure Stable Ambulatory Blood Pressure Monitoring | Tizanidine Challenge | Tizanidine Challenge Absent
Item
patients must meet criteria for stable 24 hour bp values based on the screening abpm monitorings (with and without tizanidine challenge) as determined by the study's bp consultant
boolean
C1282173 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0242876 (UMLS CUI [1,3])
C0146011 (UMLS CUI [2,1])
C0805586 (UMLS CUI [2,2])
C0146011 (UMLS CUI [3,1])
C0805586 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
CYP1A2 Inhibitors | Ciprofloxacin | Fluvoxamine | zileuton | Fluoroquinolones | Norfloxacin | Anti-Arrhythmia Agents | Amiodarone | Mexiletine | Propafenone | Cimetidine | Famotidine | Contraceptives, Oral | Acyclovir | Ticlopidine
Item
use of cyp1a2 inhibitors [e.g. ciprofloxacin or fluvoxamine as well as zileuton, other fluroquinolones (norfloxacin), antiarrythmics (amiodarone, mexiletine, propafenone), cimetidine, famotidine, oral contraceptives, acyclovir, and ticlopidine] from baseline and for the duration of the study
boolean
C3850068 (UMLS CUI [1])
C0008809 (UMLS CUI [2])
C0085228 (UMLS CUI [3])
C0081408 (UMLS CUI [4])
C0949665 (UMLS CUI [5])
C0028365 (UMLS CUI [6])
C0003195 (UMLS CUI [7])
C0002598 (UMLS CUI [8])
C0025887 (UMLS CUI [9])
C0033429 (UMLS CUI [10])
C0008783 (UMLS CUI [11])
C0015620 (UMLS CUI [12])
C0009905 (UMLS CUI [13])
C0001367 (UMLS CUI [14])
C0040207 (UMLS CUI [15])
Pharmaceutical Preparations Interfere with Investigational New Drugs | Pharmaceutical Preparations Interfere with Research results
Item
taking medications from baseline and for the duration of the study that would potentially interfere with the actions of the study medication or outcome variables as determined by the pi
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
Dementia | Mental disorders Unstable | Signs and Symptoms Disease Significant | Kidney Diseases Severe | Liver diseases Severe | Hematological Disease Severe | Endocrine System Diseases Severe | Lung diseases Severe | Heart Diseases Severe | Nervous system disorder Severe | Cerebral disorder Severe | Kidney Diseases Progressive | Liver diseases Progressive | Hematological Disease Progressive | Endocrine System Diseases Progressive | Lung diseases Progressive | Heart Diseases Progressive | Nervous system disorder Progressive | Cerebral disorder Progressive | Kidney Diseases Uncontrolled | Liver diseases Uncontrolled | Hematological Disease Uncontrolled | Endocrine System Diseases Uncontrolled | Lung diseases Uncontrolled | Heart Diseases Uncontrolled | Nervous system disorder Uncontrolled | Cerebral disorder Uncontrolled
Item
previous history of dementia, unstable psychiatric disease or current signs and symptoms of significant medical disorders such as severe, progressive or uncontrolled renal, hepatic hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease
boolean
C0497327 (UMLS CUI [1])
C0004936 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0037088 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
C0022658 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0023895 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0018939 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0014130 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0024115 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0018799 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0027765 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0234387 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0022658 (UMLS CUI [12,1])
C0205329 (UMLS CUI [12,2])
C0023895 (UMLS CUI [13,1])
C0205329 (UMLS CUI [13,2])
C0018939 (UMLS CUI [14,1])
C0205329 (UMLS CUI [14,2])
C0014130 (UMLS CUI [15,1])
C0205329 (UMLS CUI [15,2])
C0024115 (UMLS CUI [16,1])
C0205329 (UMLS CUI [16,2])
C0018799 (UMLS CUI [17,1])
C0205329 (UMLS CUI [17,2])
C0027765 (UMLS CUI [18,1])
C0205329 (UMLS CUI [18,2])
C0234387 (UMLS CUI [19,1])
C0205329 (UMLS CUI [19,2])
C0022658 (UMLS CUI [20,1])
C0205318 (UMLS CUI [20,2])
C0023895 (UMLS CUI [21,1])
C0205318 (UMLS CUI [21,2])
C0018939 (UMLS CUI [22,1])
C0205318 (UMLS CUI [22,2])
C0014130 (UMLS CUI [23,1])
C0205318 (UMLS CUI [23,2])
C0024115 (UMLS CUI [24,1])
C0205318 (UMLS CUI [24,2])
C0018799 (UMLS CUI [25,1])
C0205318 (UMLS CUI [25,2])
C0027765 (UMLS CUI [26,1])
C0205318 (UMLS CUI [26,2])
C0234387 (UMLS CUI [27,1])
C0205318 (UMLS CUI [27,2])
Laboratory test result abnormal
Item
significant abnormalities in screening laboratory parameters as described below:
boolean
C0438215 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alt > 2xuln
boolean
C0151905 (UMLS CUI [1])
Aspartate aminotransferase increased
Item
ast > 2xuln
boolean
C0151904 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine > 2.0 mg/dl
boolean
C0201976 (UMLS CUI [1])
Elevated total bilirubin
Item
bilirubin > 2xuln
boolean
C0741494 (UMLS CUI [1])
White Blood Cell Count procedure
Item
wbc < 2,300/mm3
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelets < 80,000/mm3
boolean
C0032181 (UMLS CUI [1])
Hypersensitivity Tizanidine | Hypersensitivity Tizanidine Tablet Inactive ingredient | Lactose Intolerance
Item
history of allergy to tizanidine or any inactive component (including lactose intolerance) of the sublingual tizanidine tablet
boolean
C0020517 (UMLS CUI [1,1])
C0146011 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1248220 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
C0022951 (UMLS CUI [3])
Substance Use Disorders
Item
history of substance abuse within past 12 months
boolean
C0038586 (UMLS CUI [1])
Uncooperative behavior | Informed Consent Unwilling
Item
patients who are non-cooperative or unwilling to sign consent form
boolean
C0424350 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
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