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

Primary Purpose

Optic Neuritis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
ACTHAR
Sponsored by
Neuro-Ophthalmologic Associates, PC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring acute optic neuritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Neuro Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

-ACHTHAR

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 6, 2013
Last Updated
August 17, 2017
Sponsor
Neuro-Ophthalmologic Associates, PC
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT01987167
Brief Title
Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis
Acronym
ACHTAR
Official Title
Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuro-Ophthalmologic Associates, PC
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis
Keywords
acute optic neuritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
-ACHTHAR
Arm Type
Experimental
Arm Description
Subcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU
Intervention Type
Drug
Intervention Name(s)
ACTHAR
Other Intervention Name(s)
Repository Corticotropin
Intervention Description
Injectable Gel
Primary Outcome Measure Information:
Title
Neuro-protection
Description
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 Outcome Measure Information:
Title
Preservation of retinal nerve fiber layer.
Description
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 Pre-specified Outcome Measures:
Title
Preservation and/or restoration of electrophysiological parameters for patients with acute optic neuritis.
Description
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
Title
Structural, Physiological and Metabolic changes during an acute event of optic neuritis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C Sergott, M.D.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuro Ophthalmology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28538037
Citation
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.
Results Reference
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Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis

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