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CompletedNCT01987167ACHTARUpdated Aug 22, 2017

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

An Early Phase 1 interventional study of ACTHAR in Optic Neuritis, sponsored by Neuro-Ophthalmologic Associates, PC. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Neuro-Ophthalmologic Associates, PC · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Optic Neuritis

Keywords

  • acute optic neuritis
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In context

Neuritis

116 studies on the registry are indexed under Neuritis; 21 are open to participants now.

This study's enrollment of 25 is below the median of 47 across 80 interventional studies indexed under Neuritis.

Browse Neuritis studies →

Lead sponsor

Neuro-Ophthalmologic Associates, PC is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    -ACHTHAR

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

    Drug: ACTHAR

Interventions

  • DrugACTHAR

    Injectable Gel

    Also known as: Repository Corticotropin

06

What researchers measure

Primary outcomes

  1. Neuro-protection

    Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

Other outcomes

  1. 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)

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

07

Study locations

1 site
  • Neuro Ophthalmology
    Philadelphia, Pennsylvania 19107, United States
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References and documents

Publications

  • 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. No abstract available. PubMed 28538037 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01987167
Lead sponsor
Neuro-Ophthalmologic Associates, PC
Collaborators
Mallinckrodt
Responsible party
Sponsor
First posted
Nov 19, 2013
Start date
Nov 2013
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Aug 22, 2017

Study contacts

Robert C Sergott, M.D.
principal investigator

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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