Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis (ACHTAR)
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|ClinicalTrials.gov Identifier: NCT01987167|
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Optic Neuritis||Drug: ACTHAR||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Subcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU
Other Name: Repository Corticotropin
- Neuro-protection [ Time Frame: 12 months ]Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.
- Preservation of retinal nerve fiber layer. [ Time Frame: 12 months ]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.
- Preservation and/or restoration of electrophysiological parameters for patients with acute optic neuritis. [ Time Frame: 12 months ]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)
- Structural, Physiological and Metabolic changes during an acute event of optic neuritis [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987167
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Robert C Sergott, M.D.|