ID

42688

Description

Rolipram to Treat Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00011375

Link

https://clinicaltrials.gov/show/NCT00011375

Keywords

Versions (2)
  1. 7/25/16 7/25/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00011375

English

Eligibility Multiple Sclerosis NCT00011375

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria for pre-treatment screening:
Description

ID.1

Data type

boolean

stage i:
Description

ID.2

Data type

boolean

between the ages of 18 and 65 years, inclusive.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects with clinically definite relapsing-remitting or secondary progressive multiple sclerosis according to pubished criteria.
Description

relapsing-remitting or secondary progressive multiple sclerosis

Data type

boolean

Alias
UMLS CUI [1]
C0751967
edss score between 4.0 and 6.5.
Description

edss score

Data type

boolean

Alias
UMLS CUI [1]
C0451246
patients have either failed standard treatment (interferon beta, glatiramer acetate) by clinical measures and/or were not eligible for ay of the standard treatments available or opted not to start or to continue with any of these treatments.
Description

patients failed standard treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0162643
stage ii:
Description

ID.7

Data type

boolean

same as stage i with exceptiom that edss will be between 1.5 and 6.5.
Description

edss

Data type

boolean

Alias
UMLS CUI [1]
C0451246
eligibility criteria for initiating therapy:
Description

ID.9

Data type

boolean

stage i:
Description

ID.10

Data type

boolean

subjects must have an average of up to 2 gd-enhancing lesions per month over the 3 month pre-treatment baseline period (i.e. over 4 mri scans).
Description

average of gd-enhancing lesions

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0855566
stage ii:
Description

ID.12

Data type

boolean

subjects must have an average of at least 0.5 gd-enhancing lesions per month over the 4 month pre-treatment baseline period.
Description

gd-enhancing lesions

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0855566
stage i & ii:
Description

ID.14

Data type

boolean

subjects must not have a relapse during 30 days before initiation of treatment. if a relapse occurs during the last 30 days of the pre-treatment baseline period and eligibility mri criteria are fulfilled, beginning of the treatment (day 1) is delayed for at least so many days that treatment starts not earlier than 30 days after the relapse and not earlier than 60 days in case i.v. corticosteroids had been given. similarly, the baseline needs to be prolonged if corticosteroid treatments become necessary during these three months.
Description

last relapse

Data type

boolean

Alias
UMLS CUI [1]
C0856120
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment. if a washout period of previous treatments becomes necessary, these criteria have to be assessed again at the beginning of the mri baseline period. an additional assessment of the exclusion criteria follows on day 0 of the 6 months treatment phase.
Description

exclusion criteria

Data type

boolean

medical history: blood tests exceeding any of the limits defined below will lead to exclusion from the study: alt (sgpt) or ast (sgot) is greater than three times the upper limit of normal; total white blood cell count is less than 3,000/mm(3), neutrophils less than 2,000; platelet count of less than 85, 000/mm(3); creatinine greater than 1.5 mg/dl; serology indicating hiv infection or active hepatitis a, b, or c infection; postive pregnancy test or breast-feeding female; nausea/vomiting as a frequent complaint; fasting prolactin levels of greater than 20 micrograms/l; history or signs of immunodeficiency; history of galactorrhea and/or history of prolactin-secreting tumors, history of pituitary tumors and adenomas, history of mammary tumors; clinically relevant arrhythmia or other ecg abnormalities.
Description

medical history

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0019699
UMLS CUI [8]
C1112370
UMLS CUI [9]
C0149709
UMLS CUI [10]
C0281863
UMLS CUI [11]
C0549206
UMLS CUI [12]
C0006147
UMLS CUI [13]
C0027498
UMLS CUI [14]
C0373706
UMLS CUI [15]
C0021051
UMLS CUI [16]
C3665358
UMLS CUI [17]
C0278863
UMLS CUI [18]
C0032019
UMLS CUI [19]
C1458155
UMLS CUI [20]
C0003811
UMLS CUI [21]
C0522055
clinically significant (as determined by the investigator) cardiac, immunological, pulmonary, neurological, renal, and/or other major disease including ecg, echocardiogram, and chest x-ray examinations.
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients with mental impairment that would compromise understanding and judging the consent will be excluded from the study and who are thus not able to give informed consent will be excluded fromthe study. other neurocognitive deficits or physical disabilities are no exclusion criteria.
Description

limited informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
treatment history: if prior treatment was recieved, the subject must have been off treatment for the required period prior to enrollment.
Description

prior treatment

Data type

boolean

Alias
UMLS CUI [1]
C1514463
miscellaneous: history of alcohol or drug abuse within the 5 years prior to enrollment; female subjects who are not post-menopausal or surgically sterile who are not using an acceptable method of contraception; male subjects not practicing adequate contraception; breastfeeding patients; unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returing for follow-up visits on schedule; previous participation in this study; and inability to understand/give the informed consent.
Description

substance abuse, ineffective contraception, breastfeeding, missing study compliance, study participation status, inability to give informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0006147
UMLS CUI [4]
C1321605
UMLS CUI [5]
C2348568
UMLS CUI [6,1]
C0021430
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0009488
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Similar models

Eligibility Multiple Sclerosis NCT00011375

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
inclusion criteria for pre-treatment screening:
boolean
ID.2
Item
stage i:
boolean
age
Item
between the ages of 18 and 65 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
relapsing-remitting or secondary progressive multiple sclerosis
Item
subjects with clinically definite relapsing-remitting or secondary progressive multiple sclerosis according to pubished criteria.
boolean
C0751967 (UMLS CUI [1])
edss score
Item
edss score between 4.0 and 6.5.
boolean
C0451246 (UMLS CUI [1])
patients failed standard treatment
Item
patients have either failed standard treatment (interferon beta, glatiramer acetate) by clinical measures and/or were not eligible for ay of the standard treatments available or opted not to start or to continue with any of these treatments.
boolean
C1708063 (UMLS CUI [1,1])
C0162643 (UMLS CUI [1,2])
ID.7
Item
stage ii:
boolean
edss
Item
same as stage i with exceptiom that edss will be between 1.5 and 6.5.
boolean
C0451246 (UMLS CUI [1])
ID.9
Item
eligibility criteria for initiating therapy:
boolean
ID.10
Item
stage i:
boolean
average of gd-enhancing lesions
Item
subjects must have an average of up to 2 gd-enhancing lesions per month over the 3 month pre-treatment baseline period (i.e. over 4 mri scans).
boolean
C0221198 (UMLS CUI [1,1])
C0855566 (UMLS CUI [1,2])
ID.12
Item
stage ii:
boolean
gd-enhancing lesions
Item
subjects must have an average of at least 0.5 gd-enhancing lesions per month over the 4 month pre-treatment baseline period.
boolean
C0221198 (UMLS CUI [1,1])
C0855566 (UMLS CUI [1,2])
ID.14
Item
stage i & ii:
boolean
last relapse
Item
subjects must not have a relapse during 30 days before initiation of treatment. if a relapse occurs during the last 30 days of the pre-treatment baseline period and eligibility mri criteria are fulfilled, beginning of the treatment (day 1) is delayed for at least so many days that treatment starts not earlier than 30 days after the relapse and not earlier than 60 days in case i.v. corticosteroids had been given. similarly, the baseline needs to be prolonged if corticosteroid treatments become necessary during these three months.
boolean
C0856120 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exclusion criteria
Item
patients will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment. if a washout period of previous treatments becomes necessary, these criteria have to be assessed again at the beginning of the mri baseline period. an additional assessment of the exclusion criteria follows on day 0 of the 6 months treatment phase.
boolean
medical history
Item
medical history: blood tests exceeding any of the limits defined below will lead to exclusion from the study: alt (sgpt) or ast (sgot) is greater than three times the upper limit of normal; total white blood cell count is less than 3,000/mm(3), neutrophils less than 2,000; platelet count of less than 85, 000/mm(3); creatinine greater than 1.5 mg/dl; serology indicating hiv infection or active hepatitis a, b, or c infection; postive pregnancy test or breast-feeding female; nausea/vomiting as a frequent complaint; fasting prolactin levels of greater than 20 micrograms/l; history or signs of immunodeficiency; history of galactorrhea and/or history of prolactin-secreting tumors, history of pituitary tumors and adenomas, history of mammary tumors; clinically relevant arrhythmia or other ecg abnormalities.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0019699 (UMLS CUI [7])
C1112370 (UMLS CUI [8])
C0149709 (UMLS CUI [9])
C0281863 (UMLS CUI [10])
C0549206 (UMLS CUI [11])
C0006147 (UMLS CUI [12])
C0027498 (UMLS CUI [13])
C0373706 (UMLS CUI [14])
C0021051 (UMLS CUI [15])
C3665358 (UMLS CUI [16])
C0278863 (UMLS CUI [17])
C0032019 (UMLS CUI [18])
C1458155 (UMLS CUI [19])
C0003811 (UMLS CUI [20])
C0522055 (UMLS CUI [21])
comorbidity
Item
clinically significant (as determined by the investigator) cardiac, immunological, pulmonary, neurological, renal, and/or other major disease including ecg, echocardiogram, and chest x-ray examinations.
boolean
C0009488 (UMLS CUI [1])
limited informed consent
Item
patients with mental impairment that would compromise understanding and judging the consent will be excluded from the study and who are thus not able to give informed consent will be excluded fromthe study. other neurocognitive deficits or physical disabilities are no exclusion criteria.
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
prior treatment
Item
treatment history: if prior treatment was recieved, the subject must have been off treatment for the required period prior to enrollment.
boolean
C1514463 (UMLS CUI [1])
substance abuse, ineffective contraception, breastfeeding, missing study compliance, study participation status, inability to give informed consent
Item
miscellaneous: history of alcohol or drug abuse within the 5 years prior to enrollment; female subjects who are not post-menopausal or surgically sterile who are not using an acceptable method of contraception; male subjects not practicing adequate contraception; breastfeeding patients; unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's returing for follow-up visits on schedule; previous participation in this study; and inability to understand/give the informed consent.
boolean
C0038586 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C1321605 (UMLS CUI [4])
C2348568 (UMLS CUI [5])
C0021430 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0009488 (UMLS CUI [6,3])
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