Ghrelin (OXE--103) for Acute Concussion Management

Plain-language guide to NCT04558346: phase 2 non-randomized trial of Ghrelin, concussion, traumatic brain injury & stroke recovery, 23 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04558346
Phase: phase 2
Status: completed
Start: 2020-10-20
Completion (planned or actual): 2022-10-30
Participants: 23 (actual)
Design: non-randomized, open label (everyone knows who gets what), treatment
Conditions studied: Concussion, Brain; Traumatic Brain Injury
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Ghrelin for concussion, traumatic brain injury & stroke recovery.

Concussions are the leading form of mild traumatic brain injury.

Currently, there are no FDA approved treatments for acute concussion.

It had two arms (groups): Placebo (placebo comparator) and Ghrelin (OXE-103) (experimental).

The registry classes the interventions as drug.

More on the Plan

All consenting participants will be screened for eligibility.

The study does not include randomization and all enrolling subjects will be offered treatment with OXE-103.

Enrolling subjects will also have the option to choose participation in a non-treatment control group if they do not want treatment.

Participation for the non-treatment group will last the same amount of time.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the concussion, traumatic brain injury & stroke recovery participants stayed in one arm throughout.

Everyone knew when Ghrelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-10-20 with completion listed for 2022-10-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Symptom Management - Post Concussion Symptom Scale (time frame: Days 1, 15, and 44).

It also tracked 1 secondary outcome, for example Quality of Life - QOLIBRI-OS.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Ghrelin in 23 people with concussion, traumatic brain injury & stroke recovery.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Ghrelin compound page, Concussion, traumatic brain injury & stroke recovery research.

Our Notes on the Compound

Ghrelin: A 28-amino-acid stomach hormone that signals hunger and triggers growth hormone release; studied in human trials as an infusion.

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.