ID

18305

Beschreibung

Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00654927

Link

https://clinicaltrials.gov/show/NCT00654927

Stichworte

Versionen (1)
  1. 28.10.16 28.10.16 -
Hochgeladen am

28. Oktober 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00654927

Englisch

Eligibility Multiple Sclerosis NCT00654927

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Beschreibung

Study Subject Participation Status | Clinical Trial Multiple Sclerosis | fampridine | placebo

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0026769
UMLS CUI [3]
C0000477
UMLS CUI [4]
C1696465
the subject must have multiple sclerosis as determined by the principal investigator.
Beschreibung

Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026769
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.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
the subject must be of adequate cognitive function, as judged by the investigator.
Beschreibung

Cognitive function

Datentyp

boolean

Alias
UMLS CUI [1]
C0392335
any subject who is female and of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test at the screening visit.
Beschreibung

Childbearing Potential Urine pregnancy test negative | Sex Behavior

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0036864
UMLS CUI [5]
C0020699
UMLS CUI [6]
C0278321
UMLS CUI [7]
C0520483
UMLS CUI [8]
C0021900
UMLS CUI [9]
C0009905
UMLS CUI [10]
C1262153
UMLS CUI [11]
C1168146
UMLS CUI [12]
C0004764
UMLS CUI [13,1]
C0036864
UMLS CUI [13,2]
C0443288
UMLS CUI [14]
C3843418
the subject withdrew from a previous fampridine study because of a serious adverse event that was possibly, probably or definitely related to fampridine.
Beschreibung

Study Subject Participation Status | Serious Adverse Event Related fampridine

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0000477
the subject has a history of seizures or has evidence of past, or possible, epileptiform activity on an eeg.
Beschreibung

Seizures | EEG shows epileptiform activity

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C1969872
the subject has either a clinically significant abnormal ecg or laboratory value(s) at the screening visit, as judged by the investigator
Beschreibung

Electrocardiogram abnormal Clinical Significance | LABORATORY ABNORMALITIES Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0522055
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C1853129
UMLS CUI [2,2]
C2826293
the subject has angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the investigator.
Beschreibung

Angina Pectoris | Uncontrolled hypertension | Cardiac Arrhythmia Clinical Significance | Cardiovascular Abnormalities Clinical Significance

Datentyp

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C2826293
UMLS CUI [4,1]
C0243050
UMLS CUI [4,2]
C2826293
the subject has a known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine tablet
Beschreibung

Hypersensitivity Substance Containing pyridine | Hypersensitivity fampridine inactive ingredient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0439861
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0034251
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0000477
UMLS CUI [2,3]
C1552019
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.
Beschreibung

Investigational New Drugs | 4-Aminopyridine Sustained Release | placebo matching | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C1449659
UMLS CUI [3,1]
C1696465
UMLS CUI [3,2]
C1708943
UMLS CUI [4]
C2348568
the subject has received compounded 4-aminopyridine (4-ap) within 14 days of the screening visit.
Beschreibung

dalfampridine Compounded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0000477
UMLS CUI [1,2]
C4035157
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.
Beschreibung

Multiple Sclerosis Exacerbation Onset of | Disease Exacerbation Episode Stabilized

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026769
UMLS CUI [1,2]
C0235874
UMLS CUI [1,3]
C0332162
UMLS CUI [2,1]
C0235874
UMLS CUI [2,2]
C0332189
UMLS CUI [2,3]
C0184512
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.
Beschreibung

Pharmaceutical Preparations Comorbidity | Interferon Multiple Sclerosis | Chemotherapeutic agent Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0009488
UMLS CUI [2,1]
C0021747
UMLS CUI [2,2]
C0026769
UMLS CUI [3,1]
C0729502
UMLS CUI [3,2]
C0026769
the subject has a history of drug or alcohol abuse within the past year.
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT00654927

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