Study Subject Participation Status | Clinical Trial Specified | Multiple Sclerosis | fampridine-sr | Placebo given
Item
subject must have been previously enrolled in acorda therapeutics ms-f203 study for multiple sclerosis and received either fampridine-sr or placebo
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0026769 (UMLS CUI [3])
C1449659 (UMLS CUI [4])
C0420256 (UMLS CUI [5])
Gender | Multiple Sclerosis
Item
subject is a man or woman with clinical definite multiple sclerosis as defined by mcdonald (mcdonald wi, et al. recommended diagnostic criteria for multiple sclerosis; guidelines from the international panel on the diagnosis of multiple sclerosis; annals of neurology. 2001; 50: 121-127)
boolean
C0079399 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
Age | Overall Well Being
Item
subject must be at least 18 years of age. any subject who is now over the age of 70 must be in good overall health in the judgment of the investigator
boolean
C0001779 (UMLS CUI [1])
C3813622 (UMLS CUI [2])
Cognitive functions | Informed Consent | Protocol Compliance
Item
subject must be of adequate cognitive function, as judged by the investigator, to understand and sign the irb/reb-approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol
boolean
C0392335 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C0525058 (UMLS CUI [3])
Childbearing Potential Urine pregnancy test negative | Childbearing Potential Sex Behavior
Item
subjects who are women of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the screening visit.
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0036864 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Heterosexual relationship | Female Sterilization | Postmenopausal state Duration | Childbearing Potential Contraceptive methods Lacking | Tubal Ligation | Contraceptive implant | Oral contraception | Contraceptive Patch | Injectable contraception | Transdermal contraception | Contraception, Barrier | Sex Behavior Partner had vasectomy
Item
women who are either pregnant or breastfeeding, and women of childbearing potential (defined as not surgically sterile or at least two years post menopausal) who are engaged in active heterosexual relations and, are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0556476 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4])
C0232970 (UMLS CUI [5,1])
C0449238 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0700589 (UMLS CUI [6,2])
C0332268 (UMLS CUI [6,3])
C0520483 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C0029151 (UMLS CUI [9])
C2985284 (UMLS CUI [10])
C1262153 (UMLS CUI [11])
C1168146 (UMLS CUI [12])
C0004764 (UMLS CUI [13])
C0036864 (UMLS CUI [14,1])
C0420842 (UMLS CUI [14,2])
Study Subject Participation Status | Clinical Trial Specified Discontinued
Item
subject discontinued prematurely from the ms-f203 study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
Seizures | EEG shows epileptiform activity Evidence
Item
subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an eeg
boolean
C0036572 (UMLS CUI [1])
C1969872 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
Electrocardiogram abnormal Study Subject Participation Status Exclusion | Laboratory test result abnormal Study Subject Participation Status Exclusion
Item
subject has either a clinically significant abnormal ecg or laboratory value(s) at the screening visit, as judged by the investigator that would preclude entry into the study. ecg and laboratory results from visit 6 or repeat results from visit 7 of the ms-f203 study may be used as the baseline for the current study
boolean
C0522055 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2828389 (UMLS CUI [2,3])
Angina Pectoris | Uncontrolled hypertension | Cardiac Arrhythmia | Cardiovascular Abnormalities
Item
subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the investigator
boolean
C0002962 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0243050 (UMLS CUI [4])
Hypersensitivity Pharmaceutical Preparations Containing pyridine | Hypersensitivity fampridine-sr inactive ingredient | Hypersensitivity hypromellose | Hypersensitivity microcrystalline cellulose | Hypersensitivity colloidal silicon dioxide | Hypersensitivity Magnesium stearate | Hypersensitivity opadry white
Item
subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-sr tablet (hydroxypropyl methylcellulose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, opadry white (tablet film coating))
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0034251 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C1449659 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0063242 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0669247 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0982384 (UMLS CUI [5,2])
C0020517 (UMLS CUI [6,1])
C0126791 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C1509594 (UMLS CUI [7,2])
Investigational New Drugs | fampridine-sr | Study Subject Participation Status
Item
subject has received an investigational drug, except for fampridine-sr or matching placebo under protocol ms-f203, within 30 days of the screening visit. subject is scheduled to enroll in an investigational drug trial at any time during this study.
boolean
C0013230 (UMLS CUI [1])
C1449659 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
Substance Use Disorders
Item
subject has a history of drug or alcohol abuse within the past year
boolean
C0038586 (UMLS CUI [1])