Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Neuro-Ophthalmologic Associates, PC
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

• unilateral acute demyelinating optic neuritis

• Able to provide informed consent

• age 18 or older

• can perform the above listed electrophysiologic diagnostic testing

• can perform high and low contrast visual acuity and visual field perimetry

Exclusion Criteria:

• prior diagnosis of remitting/relapsing multiple sclerosis(RRMS)

• secondary progressive MS(SPMS)

• primary progressive MS (PPMS)

• undergoing treatment with medications approve for treatment of RRMS(except corticosteroids for a condition not involving central nervous system demyelination)

• prior diagnosis of systemic lupus erythematosis

• mixed connective tissue disease

• vasculitis

• sarcoidosis

• neuro-myelitis optica