NCT04558346

Ghrelin (OXE--103) for Acute Concussion Management

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Michael Rippee · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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. An OXE-103 (ghrelin) agonist is already FDA approved for another condition, 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.

Detailed description

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. Consenting participants must be willing to commit to the following: * give themselves subcutaneous injections twice a day (for the treatment groups) * attend several study visits, which require both in-person and phone-only visits * complete various questionnaires and testing * have blood drawn * have ECG's performed * undergo a pregnancy test (if of childbearing potential) and use contraception while on study (for the treatment groups) * tell the study team about any side effects they might experience from the study drug during study participation Total participation will last about 7 weeks, which includes screening, 14 days of taking the study drug, and 4 weeks of follow-up. Participation for the non-treatment group will last the same amount of time.

Conditions

• Concussion, Brain
• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Ghrelin (OXE-103)	40ug/kg twice daily by self-injection
DRUG	Placebo	40ug/kg twice daily by self-injection

Timeline

• Start date: 2020-10-20
• Primary completion: 2022-10-30
• Completion: 2022-10-30
• First posted: 2020-09-22
• Last updated: 2024-05-21
• Results posted: 2024-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study