A Phase 2 interventional study of repository corticotropin injection and Saline in Multiple Sclerosis, sponsored by University at Buffalo. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by University at Buffalo · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is effective in the treatment of relapsing remitting multiple sclerosis.
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system (CNS). It is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue. Recent data shows that ACTH can have beneficial effects on specific neurodegenerative diseases and it may have superior neuroprotective effects. Adding a regimen of ACTH to standard Avonex treatment may provide neuroprotection and promote remyelination.
3,460 studies on the registry are indexed under Multiple Sclerosis; 660 are open to participants now.
Browse Multiple Sclerosis studies →University at Buffalo is the lead sponsor of 73 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive the hormone
Drug: repository corticotropin injection
Patients receive placebo only
Drug: Saline
IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
Also known as: H.P. Acthar gel
I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS
Effect of ACTH in MRI
Time frame: 1 year
To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. in RRMS on anterior optic pathway pathology, as measured by OCT and LCLA in patients with RRMS.
Effect of ACTH on optic health
Time frame: 1 year
This study is withdrawn, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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University at Buffalo