ID

24660

Beschreibung

Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00649792

Link

https://clinicaltrials.gov/show/NCT00649792

Stichworte

Versionen (1)
  1. 12.08.17 12.08.17 -
Hochgeladen am

12. August 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00649792

Englisch

Eligibility Multiple Sclerosis NCT00649792

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient must have been previously enrolled in the acorda therapeutics ms-f204 study and received either fampridine-sr or placebo
Beschreibung

Study Subject Participation Status | Clinical Trial Multiple Sclerosis | Fampridine-SR | placebo

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0026769
UMLS CUI [3]
C1449659
UMLS CUI [4]
C1696465
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)
Beschreibung

Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0026769
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
Beschreibung

Age | Good health

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3813622
patient must be of adequate cognitive function, as judged by the investigator
Beschreibung

Cognitive function

Datentyp

boolean

Alias
UMLS CUI [1]
C0392335
patients who are women of childbearing potential must have a negative urine pregnancy test at the screening visit
Beschreibung

Childbearing Potential Urine pregnancy test negative

Datentyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients who are either pregnant or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential who are not using a specified birth control method
Beschreibung

Childbearing Potential Contraceptive methods Lacking

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
patients discontinued prematurely from the ms-f204 study
Beschreibung

Clinical Trial Multiple Sclerosis | Patients Discontinued

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0026769
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1444662
patients with a history of seizures or with 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
patient with either a clinically significant abnormal ecg or laboratory values at the ms-f204 ext screening visit
Beschreibung

ECG abnormal | Laboratory test result abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0438215
patient with severe renal impairment
Beschreibung

Renal Insufficiency Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
patient with 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 | Cardiovascular Abnormalities

Datentyp

boolean

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

Hypersensitivity Substance Containing Pyridine | Hypersensitivity Inactive ingredient Fampridine-SR Tablet

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]
C1552019
UMLS CUI [2,3]
C1449659
UMLS CUI [2,4]
C0039225
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
Beschreibung

Investigational New Drugs | Exception Fampridine-SR | Exception Placebo | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1449659
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1696465
UMLS CUI [4]
C2348568
patient who 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 NCT00649792

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-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])
Item Group
C0680251 (UMLS CUI)
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])
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