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

NCT ID: NCT01987167

Last Updated: 2017-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-12-31

Brief Summary

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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

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Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.

Conditions

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Optic Neuritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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-ACHTHAR

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

Group Type EXPERIMENTAL

ACTHAR

Intervention Type DRUG

Injectable Gel

Interventions

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ACTHAR

Injectable Gel

Intervention Type DRUG

Other Intervention Names

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Repository Corticotropin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mallinckrodt

INDUSTRY

Sponsor Role collaborator

Neuro-Ophthalmologic Associates, PC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert C Sergott, M.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

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Neuro Ophthalmology

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 28538037 (View on PubMed)

Other Identifiers

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ACTHAR

Identifier Type: OTHER

Identifier Source: secondary_id

13-330

Identifier Type: -

Identifier Source: org_study_id

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