Status:
TERMINATED
A Trial of Neuroprotection With ACTH in Acute Optic Neuritis
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Mallinckrodt
University of Pennsylvania
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
We hypothesize that the novel melanocortin-mediated anti-inflammatory effects of ACTH will reduce axonal loss following ON by limiting inflammatory optic nerve injury. We will compare the effect of AC...
Detailed Description
Patients with their first episode of unilateral acute ON will be treated with either 3 days of IV methylprednisolone followed by 11 days of oral prednisone or 15 days of intramuscular or subcutaneous ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Ability to provide written informed consent before any study assessment is performed.
- Male and female patients aged between 18 and 55 years, inclusive.
- Diagnosis of clinically unilateral acute demyelinating optic neuritis (ADON)
- Clinical signs and symptoms of ADON starting within the 14 day prior to intended randomization (loss of vision, pain on movement, impairment of color vision).
- The qualifying episode of optic neuritis must be the first clinical episode of optic neuritis in the affected eye.
- Able to undergo treatment with intravenous methylprednisolone or Acthar gel.
- Exclusion Criteria:
- Functionally or clinically relevant comorbidity of the affected eye (e.g., glaucoma, amblyopia, optic nerve hypoplasia, macular hole, macular edema, vitreomacular traction, uveitis, diabetes, optic neuritis, or other diseases of the optic nerve or a history thereof).
- Bilateral optic neuritis.
- Concurrent functionally or clinically relevant disturbances of the eye not affected by ADON.
- High clinical likelihood of a form of optic neuritis other than ADON (e.g., no pain on movement, no light perception, severe optic disk edema, atrophic optic disk, retinal exudates, or hemorrhages).
- Non-assessable OCT at screening.
- Refractive error greater than ±5 diopters or (pre-surgical value to be used for patients having undergone refractive surgery).
- Patients with an immune system disorder other than MS or ADON (e.g. rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency). Diagnosis of neuromyelitis optica or MOG-IgG will not exclude a patient from the study but will be accounted for in the data analysis.
- Prior treatment with IVMP or Acthar gel within the past 30 days.
- Treatment with, mitoxantrone, cyclophosphamide, mycophenolate, azathioprine, or other non-approved agents for the treatment of relapsing forms of MS.
- Concurrent use of 4-aminopyridine.
Exclusion
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01838174
Start Date
May 1 2013
End Date
January 13 2022
Last Update
April 27 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Denver
Aurora, Colorado, United States, 80045
2
University of Pennsylvania Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104