Any MS relapse in the last five years, as determined at the screen visit by the PI
Any new or definitely enlarging T2/FLAIR lesion or new gadolinium-enhancing lesion within the past three years (at least two scans separated by at least three years must be reviewed) on brain or spine MRI scan. Lesions must be 3mm or larger to be exclusionary.
Significant (as defined by the PI) intolerance of presently-used DMT
Use of inhaled or topical steroids are not an exclusion criteria.
Use of oral steroids for no greater than 14 days given for a non-MS condition is not exclusionary.
alemtuzumab,
mitoxantrone,
cyclophosphamide,
methotrexate,
cyclosporine, or
rituximab
Prior use of any experimental agent used as a DMT for MS in the last five years
uncontrolled hypertension,
uncontrolled diabetes,
uncontrolled asthma, or
uncontrolled depression
Cancers other than basal cell skin cancers within the last 5 years
Unable to give informed consent or follow the protocol
Unable to undergo brain MRI
Unwilling to be randomized per this protocol
History of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)

NCT03073603_exc_T1
Condition
MS
NCT03073603_exc_T2
Condition
relapse
NCT03073603_exc_T3
Temporal
in the last five years
NCT03073603_exc_T4
Condition
T2/FLAIR lesion
NCT03073603_exc_T5
Drug
gadolinium
NCT03073603_exc_T6
Qualifier
gadolinium-enhancing
NCT03073603_exc_T7
Condition
lesion
NCT03073603_exc_T8
Temporal
within the past three years
NCT03073603_exc_T9
Multiplier
at least two
NCT03073603_exc_T10
Procedure
scans
NCT03073603_exc_T11
Temporal
separated by at least three years
NCT03073603_exc_T12
Procedure
spine MRI scan
NCT03073603_exc_T13
Procedure
rain RI scan.
NCT03073603_exc_T14
Qualifier
3mm or larger
NCT03073603_exc_T15
Condition
Lesions
NCT03073603_exc_T16
Scope
T2/FLAIR lesion or new gadolinium-enhancing lesion
NCT03073603_exc_T17
Qualifier
Significant
NCT03073603_exc_T18
Condition
intolerance
NCT03073603_exc_T19
Temporal
presently-used
NCT03073603_exc_T20
Drug
DMT
NCT03073603_exc_T21
Drug
aled or roids ar
NCT03073603_exc_T22
Drug
topical steroids
NCT03073603_exc_T23
Negation
not
NCT03073603_exc_T24
Scope
inhaled or topical steroids
NCT03073603_exc_T26
Drug
oral steroids
NCT03073603_exc_T27
Temporal
no greater than 14 days
NCT03073603_exc_T28
Condition
non-MS condition
NCT03073603_exc_T29
Negation
not
NCT03073603_exc_T31
Drug
alemtuzumab
NCT03073603_exc_T32
Drug
mitoxantrone
NCT03073603_exc_T33
Drug
cyclophosphamide
NCT03073603_exc_T34
Drug
methotrexate
NCT03073603_exc_T35
Drug
cyclosporine
NCT03073603_exc_T36
Drug
rituximab
NCT03073603_exc_T38
Condition
hypertension
NCT03073603_exc_T39
Condition
diabetes
NCT03073603_exc_T40
Condition
asthma
NCT03073603_exc_T41
Condition
depression
NCT03073603_exc_T42
Qualifier
uncontrolled
NCT03073603_exc_T43
Qualifier
uncontrolled
NCT03073603_exc_T44
Qualifier
uncontrolled
NCT03073603_exc_T45
Qualifier
uncontrolled
NCT03073603_exc_T46
Condition
Cancers
NCT03073603_exc_T47
Negation
other than
NCT03073603_exc_T48
Condition
basal cell skin cancers
NCT03073603_exc_T49
Temporal
within the last 5 years
NCT03073603_exc_T51
Procedure
brain MRI
NCT03073603_exc_T52
Mood
Unable to undergo
NCT03073603_exc_T54
Condition
chronic neurological illnesses
NCT03073603_exc_T55
Observation
History of
NCT03073603_exc_T56
Qualifier
mimic MS
NCT03073603_exc_T57
Condition
ALS
NCT03073603_exc_T58
Condition
myasthenia gravis
NCT03073603_exc_T59
Condition
chronic neuropathy
NCT03073603_exc_T60
Scope
ALS, myasthenia gravis, chronic neuropathy
NCT03073603_exc_T61
Scope
chronic neurological illnesses that might mimic MS