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OpenTrials
Completed

NCT Number: NCT01987167

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

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.

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Key information

Conditions

Optic Neuritis Cranial Nerve Diseases Eye Diseases Nervous System Diseases Optic Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Neuro Ophthalmology

Philadelphia, Pennsylvania, 19107, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTHar

Drug

Injectable Gel

Other names: Repository Corticotropin

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Neuro-Ophthalmologic Associates, PC

Other

Collaborators

  • Mallinckrodt

Registry information

Official study title

Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis

Acronym: ACHTAR

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 19, 2013
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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