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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 is a Phase 4 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 37 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01838174
The ClinicalTrials.gov registry entry for NCT01838174 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ACTHAR Gel (ACTH) is the first listed.
NCT01838174 reports 0 study locations.
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.
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