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

Early Phase 1

Completed

• Conditions: Optic Neuritis
• Interventions: Drug: ACTHAR

• Registration Number: NCT01987167
• Lead Sponsor: Neuro-Ophthalmologic Associates, PC

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
-ACHTHAR	ACTHAR	Subcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU

Primary Outcome Measures

Name	Time	Method
Neuro-protection	12 months	Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.

Secondary Outcome Measures

Name	Time	Method
Preservation of retinal nerve fiber layer.	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.

Trial Locations

Locations (1)

Neuro Ophthalmology; 🇺🇸 Philadelphia, Pennsylvania, United States