ID

11995

Description

Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01649050

Link

https://clinicaltrials.gov/show/NCT01649050

Keywords

Versions (1)
  1. 8/30/15 8/30/15 -
Uploaded on

August 30, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Muscle Spasticity Due to Multiple Sclerosis NCT01649050

English

Eligibility Muscle Spasticity Due to Multiple Sclerosis NCT01649050

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Diagnosis of multiple sclerosis (MS) of any type.
Description

Diagnosis of multiple sclerosis (MS) of any type.

Data type

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0332307
MS diagnosis at least 6 months prior to screening.
Description

MS diagnosis at least 6 months prior to screening.

Data type

boolean

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C0026769
Stable MS with no relapse within 3 months prior to screening.
Description

Stable MS with no relapse within 3 months prior to screening.

Data type

boolean

Alias
UMLS CUI [1]
C0035020
Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.
Description

Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.

Data type

boolean

Alias
UMLS CUI [1]
C0026838
UMLS CUI [2]
C0026769
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Patients with symptoms of spasticity not due to MS.
Description

Patients with symptoms of spasticity not due to MS.

Data type

boolean

Alias
UMLS CUI [1]
C0026838
Patients taking three or more different anti-spasticity medications.
Description

Patients taking three or more different anti-spasticity medications.

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0026838
Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.
Description

Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.

Data type

boolean

Alias
UMLS CUI [1]
C0235874
UMLS CUI [2]
C0026769
Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.
Description

Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.

Data type

boolean

Alias
UMLS CUI [1]
C0015980
Use of baclofen pump at any time.
Description

Use of baclofen pump at any time.

Data type

boolean

Alias
UMLS CUI [1]
C3836732
Wheelchair or bed-bound patients.
Description

Wheelchair or bed-bound patients.

Data type

boolean

Alias
UMLS CUI [1]
C0043143
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Similar models

Eligibility Muscle Spasticity Due to Multiple Sclerosis NCT01649050

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
multiple sclerosis; type
Item
Diagnosis of multiple sclerosis (MS) of any type.
boolean
C0026769 (UMLS CUI [1])
C0332307 (UMLS CUI [2])
diagnosis; multiple sclerosis
Item
MS diagnosis at least 6 months prior to screening.
boolean
C0011900 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
relapse
Item
Stable MS with no relapse within 3 months prior to screening.
boolean
C0035020 (UMLS CUI [1])
spasticity; multiple sclerosis
Item
Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications.
boolean
C0026838 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
spasticity
Item
Patients with symptoms of spasticity not due to MS.
boolean
C0026838 (UMLS CUI [1])
medications; spasticity
Item
Patients taking three or more different anti-spasticity medications.
boolean
C0013227 (UMLS CUI [1])
C0026838 (UMLS CUI [2])
Disease Exacerbation; multiple sclerosis
Item
Acute MS exacerbation requiring treatment within 3 months of the Screening Visit.
boolean
C0235874 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
interferon beta
Item
Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit.
boolean
C0015980 (UMLS CUI [1])
baclofen pump
Item
Use of baclofen pump at any time.
boolean
C3836732 (UMLS CUI [1])
wheelchair
Item
Wheelchair or bed-bound patients.
boolean
C0043143 (UMLS CUI [1])
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