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Trial record 2 of 2 for:    Acthar Gel | Optic Neuritis
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Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis (ACHTAR)

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ClinicalTrials.gov Identifier: NCT01987167
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Neuro-Ophthalmologic Associates, PC

Study Description
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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
Optic Neuritis Drug: ACTHAR 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
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Study Type : Interventional  (Clinical Trial)
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 : November 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: -ACHTHAR
Subcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU
 Drug: ACTHAR
Injectable Gel
Other Name: Repository Corticotropin


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987167


Locations
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United States, Pennsylvania
Neuro Ophthalmology
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Neuro-Ophthalmologic Associates, PC
Mallinckrodt
Investigators
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Principal Investigator: Robert C Sergott, M.D.
More Information
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Publications of Results:

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Responsible Party: Neuro-Ophthalmologic Associates, PC
ClinicalTrials.gov Identifier: NCT01987167    
Other Study ID Numbers: 13-330
ACTHAR ( Other Identifier: Questcor Pharmaceuticals, Inc. )
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Neuro-Ophthalmologic Associates, PC:
acute optic neuritis
Additional relevant MeSH terms:
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Neuritis
Optic Neuritis
Optic Nerve Diseases
Eye Diseases
Adrenocorticotropic Hormone
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs