Study Subject Participation Status | Clinical Trial Multiple Sclerosis | fampridine | placebo
Item
the subject must have been previously enrolled in an acorda therapeutics or an elan corporation sponsored study for multiple sclerosis and received either fampridine or placebo.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C0000477 (UMLS CUI [3])
C1696465 (UMLS CUI [4])
Multiple Sclerosis
Item
the subject must have multiple sclerosis as determined by the principal investigator.
boolean
C0026769 (UMLS CUI [1])
Age
Item
the subject, male or female, 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])
Cognitive function
Item
the subject must be of adequate cognitive function, as judged by the investigator.
boolean
C0392335 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative | Sex Behavior
Item
any subject who is female and 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])
C0036864 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Sex Behavior | Hysterectomy | Bilateral oophorectomy | Tubal Ligation | Intrauterine Devices | Contraceptives, Oral | Injectable contraception | Transdermal contraception | Contraception, Barrier | Sex Behavior Restricted | Vasectomy or male sterilization
Item
the subject is a female who is either pregnant or breastfeeding, or of child-bearing potential, who, if engaged in active heterosexual relations and has not had a hysterectomy or bilateral oophorectomy, would not use one of the following birth control methods: tubal ligation, implantable contraception device, oral, 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])
C0700589 (UMLS CUI [3,2])
C0036864 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0278321 (UMLS CUI [6])
C0520483 (UMLS CUI [7])
C0021900 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C1262153 (UMLS CUI [10])
C1168146 (UMLS CUI [11])
C0004764 (UMLS CUI [12])
C0036864 (UMLS CUI [13,1])
C0443288 (UMLS CUI [13,2])
C3843418 (UMLS CUI [14])
Study Subject Participation Status | Serious Adverse Event Related fampridine
Item
the subject withdrew from a previous fampridine study because of a serious adverse event that was possibly, probably or definitely related to fampridine.
boolean
C2348568 (UMLS CUI [1])
C1519255 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0000477 (UMLS CUI [2,3])
Seizures | EEG shows epileptiform activity
Item
the 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])
Electrocardiogram abnormal Clinical Significance | LABORATORY ABNORMALITIES Clinical Significance
Item
the subject has either a clinically significant abnormal ecg or laboratory value(s) at the screening visit, as judged by the investigator
boolean
C0522055 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1853129 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Angina Pectoris | Uncontrolled hypertension | Cardiac Arrhythmia Clinical Significance | Cardiovascular Abnormalities Clinical Significance
Item
the 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 [3,1])
C2826293 (UMLS CUI [3,2])
C0243050 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
Hypersensitivity Substance Containing pyridine | Hypersensitivity fampridine inactive ingredient
Item
the subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine 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])
C0000477 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
Investigational New Drugs | 4-Aminopyridine Sustained Release | placebo matching | Study Subject Participation Status
Item
the subject has received an investigational drug, except for fampridine- sr (or matching placebo) under protocol ms-f202, within 30 days prior to the screening visit; or the 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])
C1696465 (UMLS CUI [3,1])
C1708943 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4])
dalfampridine Compounded
Item
the subject has received compounded 4-aminopyridine (4-ap) within 14 days of the screening visit.
boolean
C0000477 (UMLS CUI [1,1])
C4035157 (UMLS CUI [1,2])
Multiple Sclerosis Exacerbation Onset of | Disease Exacerbation Episode Stabilized
Item
the subject has had an onset of an ms exacerbation within 30 days prior to the screening visit, or, if in the judgment of the investigator, has not stabilized from a prior exacerbation episode.
boolean
C0026769 (UMLS CUI [1,1])
C0235874 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0235874 (UMLS CUI [2,1])
C0332189 (UMLS CUI [2,2])
C0184512 (UMLS CUI [2,3])
Pharmaceutical Preparations Comorbidity | Interferon Multiple Sclerosis | Chemotherapeutic agent Multiple Sclerosis
Item
the subject has started on a concomitant medication regimen for an underlying disease/symptom within the past 7 days; or has started an interferon or chemotherapeutic agent for multiple sclerosis within the past 4 weeks.
boolean
C0013227 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0021747 (UMLS CUI [2,1])
C0026769 (UMLS CUI [2,2])
C0729502 (UMLS CUI [3,1])
C0026769 (UMLS CUI [3,2])
Substance Use Disorders
Item
the subject has a history of drug or alcohol abuse within the past year.
boolean
C0038586 (UMLS CUI [1])