Trial · Interventional

TerminatedPhase 4Registry data

A Trial of Neuroprotection With ACTH in Acute Optic Neuritis

Short name ACTHAR

NCTNCT01838174Other id13-0388

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Sponsor requested

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 37 participants (actual)
Sponsor: University of Colorado, Denver · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: May 2013
Primary completion: 13 Jan 2022
Completion: 13 Jan 2022
First posted: 23 Apr 2013 (estimated)
Last update posted: 27 Apr 2023
Conditions: Multiple Sclerosis

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20142016201820202022

Ph 4
ACTHAR
NCT01838174
May 2013 to 13 Jan 2022
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 ACTH and intravenous methylprednisolone therapy on axonal injury following ON using OCT, a sensitive, reproducible and noninvasive tool to measure RNFL thickness. The primary outcome will be the average RNFL thickness at 6 months. Additional pre-specified statistical analyses will compare the difference in the mean RNFL thickness at 6 months in the affected eye between the IV methylprednisolone- and Acthar-treated groups, and the mean 6-month affected eye RNFL thicknesses adjusted for the baseline unaffected eye RNFL. The secondary outcome measure will examine the frequency of optic nerves with RNFL swelling between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months. A predefined exploratory outcome will compare the ganglion cell plus inner plexiform layer (GC+IPL) thickness at 6 months between treatment groups. Additional tertiary outcome will be the assessment of changes in fatigue, mood, visual function depression, and quality of life in patients with AON. Assessment will be completed by administration of the following questionnaires: Modified Fatigue Impact Scale, Multiple Sclerosis Quality of Life 54 Instrument, 25-item Visual Function Questionnaire with 10-item supplement, Beck's Depression Inventory. These questionnaires have been validated for the MS (AON) population. Descriptive and correlative analysis will be done at each visit time point to assess for QOL for this study population.

Interventions

ACTHAR Gel (ACTH)Drug
IV methylprednisolone (steroids)Drug

Arms2

Experimental
Acthar Gel (ACTH)
15 days of intramuscular (IM) or sub-cutaneous corticotropin (SQ) Acthar (ACTH).
Active comparator
IV methylprednisolone (steroids)
3 days of IV methylprednisolone (steroids) followed by 11 days of oral prednisone

Primary outcomes1

Outcomes the sponsor listed as primary.

Retinal Nerve Fiber Layer (RNFL) thickness
Time frame · 6 months
Registry description
The primary outcome will be the average RNFL thickness at 6 months.

Secondary outcomes(1)

Frequency of RNFL swelling
Time frame · 1 and 3 months
Registry description
The secondary outcome measure will examine the frequency of optic nerves with RNFL swelling between the IV methylprednisolone- and Acthar-treated groups at 1 and 3 months.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

6 results

A Randomized Prospective Trial Comparing Repository Corticotropin Injection and Intravenous Methylprednisolone for Neuroprotection in Acute Optic Neuritis.

Bennett et al. 2023Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Societycited by 1

PMID 37261907PMC10414149DOI 10.1097/wno.0000000000001878PUB-37261907

Free to read · publisher termsCC BY-NC-ND6 results

Read at source See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion criteria 1. Ability to provide written informed consent before any study assessment is performed. 2. Male and female patients aged between 18 and 55 years, inclusive. 3. Diagnosis of clinically unilateral acute demyelinating optic neuritis (ADON) 4. 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). 5. The qualifying episode of optic neuritis must be the first clinical episode of optic neuritis in the affected eye. 6. Able to undergo treatment with intravenous methylprednisolone or Acthar gel. Exclusion Criteria: 1. 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). 2. Bilateral optic neuritis. 3. Concurrent functionally or clinically relevant disturbances of the eye not affected by ADON. 4. 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). 5. Non-assessable OCT at screening. 6. Refractive error greater than ±5 diopters or (pre-surgical value to be used for patients having undergone refractive surgery). 7. 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. 8. Prior treatment with IVMP or Acthar gel within the past 30 days. 9. Treatment with, mitoxantrone, cyclophosphamide, mycophenolate, azathioprine, or other non-approved agents for the treatment of relapsing forms of MS. 10. Concurrent use of 4-aminopyridine.

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