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Protein Hormone

Ghrelin (OXE-103) for Concussion

Phase 2
Waitlist Available
Research Sponsored by Michael Rippee, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In Part A (post-acute), subjects must be consented within 28 days post injury. In Part B (acute), subjects must be consented, randomized, and start treatment within 24 hours of presentation to the University of Kansas Health System Trauma Unit.
Subjects in both Part A and B will have a symptom severity score of at least 20 at the time of randomization in order to reduce the expected degree (number and severity) of spontaneous symptom resolution prior to study completion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-44
Awards & highlights

Study Summary

This trial will test if a protein hormone, OXE-103, can help improve symptoms of concussion. OXE-103 is identical to the hormone ghrelin, which is secreted by the stomach, and is already FDA approved for another condition. The goal of this study is to show improvement in the way study participants feel or function after concussion.

Eligible Conditions
  • Concussion
  • Traumatic Brain Injury

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-44
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1-44 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Symptom Management - Post Concussion Symptom Scale
Secondary outcome measures
Quality of Life - PGAS
Quality of Life - QOLIBRI-OS

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ghrelin (OXE-103)Experimental Treatment1 Intervention
OXE-103 (40ug/kg) will be self-administered twice daily for 14 days. PART A (POST-ACUTE) SUBJECTS WILL BE OFFERED EXPERIMENTAL TREATMENT WITHOUT RANDOMIZATION. PART B (ACUTE) SUBJECTS WILL BE DOUBLE-BLIND RANDOMIZED TO EXPERIMENTAL OR PLACEBO TREATMENT.
Group II: PlaceboPlacebo Group1 Intervention
Placebo (40ug/kg) will be self-administered twice daily for 14 days. ONLY THE PART B (ACUTE) SUBJECTS WILL BE RANDOMIZED AND MAY RECEIVE PLACEBO.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ghrelin (OXE-103)
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Michael Rippee, MDLead Sponsor
University of Kansas Health SystemUNKNOWN
University of Kansas Medical CenterOTHER
458 Previous Clinical Trials
169,068 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~5 spots leftby Mar 2025