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

August 17, 2017 updated by: Neuro-Ophthalmologic Associates, PC

Potential Neuroprotection With ACTHAR Following 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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Neuro Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuro-Ophthalmologic Associates, PC

Collaborators

Mallinckrodt

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (ESTIMATE)

November 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-330
  • ACTHAR (OTHER: Questcor Pharmaceuticals, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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