Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Minnesota
With
Mallinckrodt
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients with a confirmed diagnosis of MS by McDonald criteria
Age \>/= 18 years
SPMS, PPMS, or PRMS phenotype, according to Lublin and Reingold criteria
EDSS 2.0 - 6.0, inclusive
Able to understand the consent process
You may not be if
Known intolerance of ACTH or corticosteroids
Diabetes mellitus, defined as pre-existing diagnosis, fasting blood glucose \> 125 mg/dl, or glycosylated hemoglobin \>/= 6.5%
Osteoporosis, defined as pre-existing diagnosis or T-score on dual-energy x-ray absorptiometry (DEXA) scan of \</= -2.5.
Current serious medical condition which may interfere with subject's ability to complete the study, or for which pulsed ACTH therapy is contraindicated or might complicate current therapy (e.g., cancer, severe psychiatric illness, chronic infections, autoimmune disorders)
Treatment with cytotoxic agents (including but not necessarily limited to mitoxantrone, cyclophosphamide, alemtuzumab, or rituximab) within 3 years prior to randomization
Treatment with non-cytotoxic immunosuppressive agents (including but not necessarily limited to corticosteroids, ACTH, azathioprine, mycophenolate mofetil, methotrexate or natalizumab) within 3 months prior to randomization
Treatment with FDA-approved first-line MS disease-modifying therapies (B-interferon, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) will be permitted, as long as treatment has been ongoing and stable for at least 3 months prior to randomization
Treatment with dalfampridine or compounded 4-aminopyridine (4-AP) will be permitted as long as treatment has been ongoing and stable for at least 3 months prior to randomization
Stimulant medications for fatigue (such as methylphenidate, modafinil, armodafinil, amantadine or dextroamphetamine) will be permitted, but subjects will be asked to not take these medications on study visit days until all study procedures/assessments are completed.
