Oral Guanabenz for Multiple Sclerosis

INCLUSION CRITERIA:
MS as defined by the 2010 Revised McDonald MS Diagnostic Criteria (19)
Age 18-55, inclusive, at the time of the first screening baseline visit
EDSS 1.0 to 6, inclusive, at the time of the first screening baseline visit
Able to provide informed consent
Willing and able to participate in all aspects of trial design and follow-up
Undergoing treatment with glatiramer acetate for a period of at least 1 year prior to enrollment in the study
For female patients, agreeing to commit to the use of a reliable/accepted method of birth control (i.e. hormonal contraception, including

birth control pills, injected hormones, and vaginal ring; intrauterine device; barrier methods with spermicide, including diaphragm and condom; or surgical sterilization, including hysterectomy, tubal ligation, and vasectomy) for the duration of the study

ADDITIONAL INCLUSION CRITERION FOR ACTIVE MS COHORT

-Development of new T2 hyperintense or contrast enhancing lesions by MRI during the screening phase, but 3 such lesions on any single scan

EXCLUSION CRITERIA:

Alternative diagnoses that better explain neurological disability and MRI findings
Clinically significant medical condition that, in the best judgment of the investigators, may expose the patient to undue risk of harm or prevent the patient from completing the study (examples include, but are not limited to, cerebrovascular disease, substance abuse, ischemic cardiomyopathy, clotting disorder, brittle diabetes, neurodegenerative disorder)
Undergoing treatment with medications that may interact with guanabenz, including anti-hypertensive agents and/or agents leading to increase in catecholamines (such as tricyclic antidepressants and monoamine oxidase inhibitors)
Medical contraindication to MRI
Determination, in the best judgment of the investigators, of the need to treat a prospective participant with steroids for management of MS during the screening period
Pregnant or breastfeeding woman
Abnormal screening/baseline blood tests exceeding any of the limits defined below:

A) Serum alanine transaminase or aspartate transaminase levels greater than 3 times the upper limit of normal values

B) Total white blood cell count < 3000/mm3

C) Platelet count < 85000/mm3

D) Serum creatinine level > 2.0 mg/dl and eGFR (estimated glomerular filtration rate) < 60

ADDITIONAL EXCLUSION CRITERIA FOR STABLE MS COHORT

Evidence of 1 or more clearly documented MS relapses within the last 1 year
Development of more than 2 lesions per year relative to an MRI performed at least one year before the first screening MRI (the prior MRI can be an outside MRI)
Development of new T2 hyperintense or contrast-enhancing lesions by MRI during the screening phase