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Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis
Plain-language guide to NCT01987167: early phase 1 interventional trial of ACTH (Corticotropin), 25 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01987167
- Phase
- early phase 1
- Status
- completed
- Start
- 2013-11
- Completion (planned or actual)
- 2016-12
- Participants
- 25 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Optic Neuritis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this early phase 1 trial, researchers set out to test ACTH (Corticotropin).
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.
It had 1 arm (groups): -ACHTHAR (experimental).
The registry classes the interventions as drug.
More on the Plan
Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
Who Took Part
The registry lists 25 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: 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.
The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: prior diagnosis of remitting/relapsing multiple sclerosis(rrms); secondary progressive ms(spms); primary progressive ms (ppms).
How the Study Was Run
Design: single-group and open-label.
Being open-label, the ACTH (Corticotropin) study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2013-11 with completion listed for 2016-12.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example Preservation of retinal nerve fiber layer.
What This Means in Plain Language
Put simply, this is a early phase 1 trial of ACTH (Corticotropin) in 25 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the ACTH (Corticotropin) compound page, all human trials.
Our Notes on the Compound
ACTH (Corticotropin): The 39-amino-acid pituitary hormone that drives cortisol production; given as repository corticotropin (Acthar Gel).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.