Informed Consent
Item
1. patient must give written informed consent;
boolean
C0021430 (UMLS CUI [1])
Multiple Sclerosis Early | Clinically isolated syndrome | Episode Suggestive of Demyelination | Demyelination Affecting Optic Nerve | Demyelination Affecting Brain Stem | Demyelination Affecting Spinal Cord | Demyelination Affecting Central Nervous System Location
Item
2. patients with a early ms or clinically isolated syndromes (cis) in the past 12 months as defined by an acute or sub-acute episode suggestive of demyelination affecting the optic nerves, brain stem or spinal cord or other central nervous system location.
boolean
C0026769 (UMLS CUI [1,1])
C1279919 (UMLS CUI [1,2])
C2921627 (UMLS CUI [2])
C0332189 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0011304 (UMLS CUI [3,3])
C0011304 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0029130 (UMLS CUI [4,3])
C0011304 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0006121 (UMLS CUI [5,3])
C0011304 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0037925 (UMLS CUI [6,3])
C0011304 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C3714787 (UMLS CUI [7,3])
C0450429 (UMLS CUI [7,4])
Age
Item
3. entry age 18-55
boolean
C0001779 (UMLS CUI [1])
Gender
Item
4. males and females
boolean
C0079399 (UMLS CUI [1])
Magnetic resonance imaging of brain: T2 weighted White matter
Item
5. at least 2 silent t2 bright areas in the deep white matter on screening brain mri.
boolean
C2238849 (UMLS CUI [1,1])
C0682708 (UMLS CUI [1,2])
Riluzole | Interferon | Copaxone | Cyclophosphamide | Mitoxantrone | Immunosuppressive Agents Off-label | Multiple Sclerosis
Item
6. no riluzole, interferon, copaxone, cyclophosphamide, mitoxantrone or other off-label immunosuppressive drugs for ms prior to study entry
boolean
C0073379 (UMLS CUI [1])
C0021747 (UMLS CUI [2])
C0528175 (UMLS CUI [3])
C0010583 (UMLS CUI [4])
C0026259 (UMLS CUI [5])
C0021081 (UMLS CUI [6,1])
C2986467 (UMLS CUI [6,2])
C0026769 (UMLS CUI [7])
Adrenal Cortex Hormones
Item
7. no corticosteroid during the 4 weeks prior to baseline mri exam
boolean
C0001617 (UMLS CUI [1])
Lymphatic Irradiation Total Exposure to
Item
8. no prior exposure to total lymphoid irradiation
boolean
C0024230 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0332157 (UMLS CUI [1,3])
Substance Use Disorders | Alcoholic Intoxication, Chronic | Alcoholic liver damage | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
9. no history of substance abuse, including documented alcohol dependence within 6 months prior to screening or alcohol liver damage with ast , alt > twice upper normal limits
boolean
C0038586 (UMLS CUI [1])
C0001973 (UMLS CUI [2])
C1442981 (UMLS CUI [3])
C0151904 (UMLS CUI [4])
C0151905 (UMLS CUI [5])
Pregnancy | Breast Feeding
Item
10. no pregnant or nursing patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Systemic disease MRI gadolinium-enhanced Limited | Medical condition MRI gadolinium-enhanced Limited | Hypersensitivity Riluzole | Hypersensitivity Riluzole Component | Uncontrolled hypertension | Epilepsy | Diabetes Mellitus, Insulin-Dependent | Asthma | Malignant Neoplasms | Skin carcinoma | Heart Disease Symptomatic | Metallic Object Body
Item
11. no history of systemic illness or medical condition that would limit the likelihood of completing the gadolinium-enhanced mri procedures. automatic exclusionary conditions will include hypersensitivity reaction to riluzole or any of the tablets components, uncontrolled hypertension, epilepsy, and insulin dependent diabetes, asthma, known malignancy other than skin cancer, symptomatic cardiac disease or metallic objects on or inside the body.
boolean
C0442893 (UMLS CUI [1,1])
C0855566 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0855566 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0073379 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0073379 (UMLS CUI [4,2])
C1705248 (UMLS CUI [4,3])
C1868885 (UMLS CUI [5])
C0014544 (UMLS CUI [6])
C0011854 (UMLS CUI [7])
C0004096 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C0699893 (UMLS CUI [10])
C0018799 (UMLS CUI [11,1])
C0231220 (UMLS CUI [11,2])
C2826620 (UMLS CUI [12,1])
C0242821 (UMLS CUI [12,2])
Contraceptive methods Willing
Item
12. patients willing to use birth control during the study.
boolean
C0700589 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Avonex Willing | Medical contraindication Interferon therapy
Item
13. patients willing to go on avonex therapy 3 months after being randomized to study drug and no contra-indication to use of interferon therapy.
boolean
C0594372 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0279030 (UMLS CUI [2,2])
Major Depressive Disorder | Psychotic Disorders
Item
1. a history of major depression or psychosis.
boolean
C1269683 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Exacerbation of multiple sclerosis
Item
2. a clinically significant ms exacerbation within 30 days of the screening
boolean
C0581392 (UMLS CUI [1])
Pregnancy
Item
3. pregnancy
boolean
C0032961 (UMLS CUI [1])
Liver Dysfunction | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
4. abnormal screening liver function (ast or alt > twice the upper normal limit).
boolean
C0086565 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Pharmaceutical Preparations Hepatotoxic effect | Pharmaceutical Preparations Interfere with Cytochrome P-450 CYP1A2
Item
5. patients receiving hepatotoxic medications such as drugs interfering with cyp 1a2.
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0207509 (UMLS CUI [2,3])