Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis
ACHTAR
Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis
2 other identifiers
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Nov 2013
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 6, 2013
CompletedFirst Posted
Study publicly available on registry
November 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 22, 2017
August 1, 2017
3.1 years
November 6, 2013
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neuro-protection
Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.
12 months
Secondary Outcomes (1)
Preservation of retinal nerve fiber layer.
12 months
Other Outcomes (2)
Preservation and/or restoration of electrophysiological parameters for patients with acute optic neuritis.
12 months
Structural, Physiological and Metabolic changes during an acute event of optic neuritis
12 months
Study Arms (1)
-ACHTHAR
EXPERIMENTALSubcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuro-Ophthalmologic Associates, PClead
- Mallinckrodtcollaborator
Study Sites (1)
Neuro Ophthalmology
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
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.
PMID: 28538037RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert C Sergott, M.D.
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2013
First Posted
November 19, 2013
Study Start
November 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
August 22, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share