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

Optic Neuritis Clinical Trial

— ACHTAR  

Official title:

Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987167
• Other study ID #: 13-330
• Secondary ID: ACTHAR
• Status: Completed
• Phase: Early Phase 1
• First received: November 6, 2013
• Last updated: August 17, 2017
• Start date: November 2013
• Est. completion date: December 2016

Study information

• Verified date: August 2017
• Source: Neuro-Ophthalmologic Associates, PC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuritis
• Optic Neuritis

Intervention

Drug:
• ACTHAR
Injectable Gel

Locations

Country	Name	City	State
United States	Neuro Ophthalmology	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Neuro-Ophthalmologic Associates, PC	Mallinckrodt

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Structural, Physiological and Metabolic changes during an acute event of optic neuritis	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
Primary	Neuro-protection	Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.	12 months
Secondary	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