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

Sponsor
Neuro-Ophthalmologic Associates, PC (Other)
Overall Status
Completed
CT.gov ID
NCT01987167
Collaborator
Mallinckrodt (Industry)
25
Enrollment
1
Location
1
Arm
37
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: -ACHTHAR

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

Drug: ACTHAR
Injectable Gel
Other Names:
  • Repository Corticotropin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Other Outcome Measures

    1. Preservation and/or restoration of electrophysiological parameters for patients with acute optic neuritis. [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Neuro Ophthalmology Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Neuro-Ophthalmologic Associates, PC
    • Mallinckrodt

    Investigators

    • Principal Investigator: Robert C Sergott, M.D.,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Neuro-Ophthalmologic Associates, PC
    ClinicalTrials.gov Identifier:
    NCT01987167
    Other Study ID Numbers:
    • 13-330
    • ACTHAR
    First Posted:
    Nov 19, 2013
    Last Update Posted:
    Aug 22, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Neuro-Ophthalmologic Associates, PC
    acute optic neuritis
    Additional relevant MeSH terms:
    Neuritis
    Optic Neuritis
    Adrenocorticotropic Hormone

    Study Results

    No Results Posted as of Aug 22, 2017