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

Neuro-Ophthalmologic Associates, PC

Status and phase: Completed; Early Phase 1

Conditions: Optic Neuritis

Treatments: Drug: ACTHAR

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01987167

ACTHAR

13-330

Details and patient eligibility

About

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.

Full description

Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

-ACHTHAR

Experimental group

Description:

Subcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU

Treatment:

Drug: ACTHAR