Ghrelin (OXE--103) for Acute Concussion Management
Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Concussions are the leading form of mild traumatic brain injury. Management of concussions
and mild traumatic brain injury is a high priority medical focus, social concern, and
research topic. Currently, there are no FDA approved treatments for acute concussion. The
current standard of care is rest followed by gradual return to normal activity. The purpose
of this study is to show improvement in the way patients feel or function after a concussion.
OXE-103 is a protein hormone produced in the laboratory which identical to the hormone
ghrelin that is secreted by the stomach. This study will investigate the use of this hormone
as treatment for symptoms of acute concussion. The goal of this study is to show improvement
in the way study participants feel or function after concussion.
OXE-103 is already FDA approved for other conditions, but not for concussion. For concussion,
it is considered investigational.
This study will examine, if ghrelin is taken every day for two weeks, if the brain will heal
faster and help improve or resolve symptoms. The study will also include a placebo arm and a
non-treatment group (for those who wish to participate but do not want to receive any
treatment). The OXE-103 and placebo will be self-administered through injections using
needles.
Phase:
Phase 2
Details
Lead Sponsor:
Michael Rippee, MD
Collaborators:
University of Kansas Health System University of Kansas Medical Center