Ghrelin (OXE--103) for Acute Concussion Management
Condition: Concussion, Brain; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional
Phase: Phase 2

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 has two Parts:

      Part A: Post-Acute (within 28 days of injury) Part B: Acute (within 24 hours of injury)

      Part A does not include randomization and all enrolling subjects will be offered treatment
      with OXE-103. Enrolling subjects in this Part A will also have the option to choose
      participation in a non-treatment control group if they do not want treatment.

      Part B participation includes double-blinded randomization to receive either OXE-103 or
      placebo. There is no option to choose participation in a non-treatment control group.

      For Part B, consenting and eligible participants will either be randomized to receive study
      drug (OXE-103) or placebo. The study team will also be blinded to the assigned treatment, so
      they will not know which treatment participants have been assigned to take.

      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 for the treatment groups 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.
    

Intervention name(s): Ghrelin (OXE-103); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40ug/kg twice daily by self-injection; 40ug/kg twice daily by self-injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment