ACTH in Progressive Forms of MS
Status: | Recruiting |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/27/2019 |
Start Date: | October 2013 |
End Date: | March 2022 |
Contact: | Susan Rolandelli, RN |
Email: | cnru@umn.edu |
Phone: | 612-624-7745 |
Treatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel)
This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to
evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar
gel) administered as a pulsed regimen consisting of injections on three consecutive days per
month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be
randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1)
pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of
clinical and paraclinical measures of MS progression compared to placebo.
evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar
gel) administered as a pulsed regimen consisting of injections on three consecutive days per
month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be
randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1)
pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of
clinical and paraclinical measures of MS progression compared to placebo.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
We found this trial at
3
sites
Milwaukee, Wisconsin 53215
Principal Investigator: Bhupendra Khatri, MD
Phone: 414-769-4013
Click here to add this to my saved trials
Fargo, North Dakota 58103
Principal Investigator: Susan Scarberry, MD
Phone: 701-234-4091
Click here to add this to my saved trials
Minneapolis, Minnesota 55414
Principal Investigator: Adam F Carpenter, MD
Phone: 612-624-7745
Click here to add this to my saved trials