Study Subject Participation Status | Clinical Trial Multiple Sclerosis | Fampridine-SR | placebo
Item
patient must have been previously enrolled in the acorda therapeutics ms-f204 study and received either fampridine-sr or placebo
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C1449659 (UMLS CUI [3])
C1696465 (UMLS CUI [4])
Multiple Sclerosis
Item
patient with clinically defined multiple sclerosis (the diagnostic criteria based on: 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
C0026769 (UMLS CUI [1])
Age | Good health
Item
patient must be at least 18 years of age. any patient 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 function
Item
patient must be of adequate cognitive function, as judged by the investigator
boolean
C0392335 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative
Item
patients who are women of childbearing potential must have a negative urine pregnancy test at the screening visit
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
female patients who are either pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Lacking
Item
women of childbearing potential who are not using a specified birth control method
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Clinical Trial Multiple Sclerosis | Patients Discontinued
Item
patients discontinued prematurely from the ms-f204 study
boolean
C0008976 (UMLS CUI [1,1])
C0026769 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
Seizures | EEG shows epileptiform activity
Item
patients with a history of seizures or with evidence of past, or possible epileptiform activity on an eeg
boolean
C0036572 (UMLS CUI [1])
C1969872 (UMLS CUI [2])
ECG abnormal | Laboratory test result abnormal
Item
patient with either a clinically significant abnormal ecg or laboratory values at the ms-f204 ext screening visit
boolean
C0522055 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
Renal Insufficiency Severe
Item
patient with severe renal impairment
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Angina Pectoris | Uncontrolled hypertension | Cardiac Arrhythmia | Cardiovascular Abnormalities
Item
patient with 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 Substance Containing Pyridine | Hypersensitivity Inactive ingredient Fampridine-SR Tablet
Item
patient with a known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-sr tablet
boolean
C0020517 (UMLS CUI [1,1])
C0439861 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0034251 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C1552019 (UMLS CUI [2,2])
C1449659 (UMLS CUI [2,3])
C0039225 (UMLS CUI [2,4])
Investigational New Drugs | Exception Fampridine-SR | Exception Placebo | Study Subject Participation Status
Item
patient who has received an investigational drug (other than fampridine-sr or placebo under ms-f204 study) within 30 days of the ms-f204ext screening visit or a patient who is scheduled to enroll in an investigational drug trial at any time during this study
boolean
C0013230 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1449659 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1696465 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4])
Substance Use Disorders
Item
patient who has a history of drug or alcohol abuse within the past year
boolean
C0038586 (UMLS CUI [1])