ID

21985

Beskrivning

Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00648908

Länk

https://clinicaltrials.gov/show/NCT00648908

Nyckelord

Versioner (1)
  1. 2017-05-12 2017-05-12 -
Uppladdad den

12 maj 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00648908

Engelsk

Eligibility Multiple Sclerosis NCT00648908

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must have been previously enrolled in acorda therapeutics ms-f203 study for multiple sclerosis and received either fampridine-sr or placebo
Beskrivning

Study Subject Participation Status | Clinical Trial Specified | Multiple Sclerosis | fampridine-sr | Placebo given

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
UMLS CUI [3]
C0026769
UMLS CUI [4]
C1449659
UMLS CUI [5]
C0420256
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)
Beskrivning

Gender | Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0026769
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
Beskrivning

Age | Overall Well Being

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3813622
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
Beskrivning

Cognitive functions | Informed Consent | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0392335
UMLS CUI [2]
C0021430
UMLS CUI [3]
C0525058
subjects who are women of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the screening visit.
Beskrivning

Childbearing Potential Urine pregnancy test negative | Childbearing Potential Sex Behavior

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0036864
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0556476
UMLS CUI [4]
C0015787
UMLS CUI [5,1]
C0232970
UMLS CUI [5,2]
C0449238
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0700589
UMLS CUI [6,3]
C0332268
UMLS CUI [7]
C0520483
UMLS CUI [8]
C1657106
UMLS CUI [9]
C0029151
UMLS CUI [10]
C2985284
UMLS CUI [11]
C1262153
UMLS CUI [12]
C1168146
UMLS CUI [13]
C0004764
UMLS CUI [14,1]
C0036864
UMLS CUI [14,2]
C0420842
subject discontinued prematurely from the ms-f203 study
Beskrivning

Study Subject Participation Status | Clinical Trial Specified Discontinued

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C1444662
subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an eeg
Beskrivning

Seizures | EEG shows epileptiform activity Evidence

Datatyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2,1]
C1969872
UMLS CUI [2,2]
C0332120
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
Beskrivning

Electrocardiogram abnormal Study Subject Participation Status Exclusion | Laboratory test result abnormal Study Subject Participation Status Exclusion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C2828389
subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the investigator
Beskrivning

Angina Pectoris | Uncontrolled hypertension | Cardiac Arrhythmia | Cardiovascular Abnormalities

Datatyp

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0003811
UMLS CUI [4]
C0243050
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))
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0034251
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1449659
UMLS CUI [2,3]
C1552019
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0063242
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0669247
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0982384
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C0126791
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C1509594
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.
Beskrivning

Investigational New Drugs | fampridine-sr | Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C1449659
UMLS CUI [3]
C2348568
subject has a history of drug or alcohol abuse within the past year
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Multiple Sclerosis NCT00648908

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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