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NCT01838174 · ClinicalTrials.gov registry record · Phase 4
A Trial of Neuroprotection With ACTH in Acute Optic Neuritis
A Phase 4 study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT01838174: Clinical Trial Phase 4 study, sponsored by University of Colorado, Denver.
NCT01838174 is a Phase 4 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 37 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01838174, a Phase 4 study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study 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 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.
Primary Outcome
The primary outcome will be the average RNFL thickness at 6 months.
Interventions
- DRUG ACTHAR Gel (ACTH)
- DRUG IV methylprednisolone (steroids)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2013-05 |
| Est. Completion | 2022-01-13 |
| Phase | Phase 4 |
Why NCT01838174 stopped before completion
NCT01838174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which ACTHAR Gel (ACTH) is the first listed.
NCT01838174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01838174 about?
NCT01838174 is a clinical study titled "A Trial of Neuroprotection With ACTH in Acute Optic Neuritis". 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, ...
What is the current status of trial NCT01838174?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2013-05. Estimated completion is 2022-01-13.
What interventions are being tested in trial NCT01838174?
The interventions under investigation include: ACTHAR Gel (ACTH) (DRUG), IV methylprednisolone (steroids) (DRUG).
Who is sponsoring clinical trial NCT01838174?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01838174's enrollment target sits among peer trials
37 1482nd of 2000 higher than 511 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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