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| ID | Type | Description | Link |
|---|---|---|---|
| NDA 08-372 |
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Difficult to recruit due to protocol requirements - participant burden.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrenocorticotropin hormone | Active Comparator | Patients receive the hormone |
|
| Placebo | Placebo Comparator | Patients receive placebo only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repository corticotropin injection | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Zivadinov, MD, PhD | Buffalo Neuroimaging Analysis Center | Principal Investigator |
| Bianca Weinstock-Guttman, MD | Jacobs Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo, Buffalo General Hospital | Buffalo | New York | 14203 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Saline | Drug | I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months. |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017670 |
| Sodium Compounds |