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| ID | Type | Description | Link |
|---|---|---|---|
| ACTHAR | Other Identifier | Questcor Pharmaceuticals, Inc. |
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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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The goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| -ACHTHAR | Experimental | Subcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTHAR | Drug | Injectable Gel |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Neuro-protection | Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Preservation of retinal nerve fiber layer. | To define the objective (micron thickness, volumetric analysis) and subjective (histopathological changes) of spectral domain optical coherence tomography (SD-OCT) at the time of clinical presentation of acute optic neuritis and during 6 months of recovery following ACTHAR treatment. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Preservation and/or restoration of electrophysiological parameters for patients with acute optic neuritis. | To define the electrophysiological changes at the onset and following an acute event of optic neuritis with Multifocal electroretinography(mERG) and visual evoked potentials (VEP) | 12 months |
| Structural, Physiological and Metabolic changes during an acute event of optic neuritis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert C Sergott, M.D. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuro Ophthalmology | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28538037 | Result | Moster ML, Sergott RC, Leiby BE. Dalfampridine Treatment in Nonarteritic Anterior Ischemic Optic Neuropathy. J Neuroophthalmol. 2017 Sep;37(3):348-349. doi: 10.1097/WNO.0000000000000523. No abstract available. |
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| ID | Term |
|---|---|
| D009902 | Optic Neuritis |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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to determine the earliest structural, physiological, and metabolic changes in the optic nerve during an acute event of demyelinating optic neuritis and the natural history of these changes over 6 months. |
| 12 months |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |