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])
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])