Ghrelin (OXE--103) for Acute Concussion Management
Purpose
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.
Conditions
- Concussion, Brain
- Traumatic Brain Injury
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
INCLUSION AND EXCLUSION:
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.
Subjects with pre-existing neurologic conditions other than mTBI (including cognitive
dysfunction) will be excluded.
Subjects with concurrent long bone fractures or orbital fractures will be excluded.
Subjects receiving, or planning to receive, a continuous ketamine infusion while enrolled
in study will be excluded.
Subjects with these known endocrinological abnormalities at baseline will be excluded from
study: diabetes mellitus, excess or deficiency of growth hormone, cortisol, or prolactin.
Exclusion from study for any other endocrinological abnormalities or diagnoses existing at
baseline are ultimately up to the discretion of the study physician.
Significant abnormalities in serum creatinine (>2.5 mg/dL), or alanine aminotransferase
(ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal, or bilirubin
(>2.5 mg/dL) will exclude subjects from participation.
Subjects with any abnormal findings noted on imaging, such as hemorrhage, will be excluded
from the study. Subjects who meet criteria for moderate or severe TBI will also be
excluded.
Subjects who are known to be pregnant will be excluded. Subjects who do not agree to
double-barrier contraception or abstinence (for female subjects of child-bearing potential
or male subjects who are sexually active with a female of child-bearing potential) until
the day following last dose (total of at least 5 half-lives) will be excluded.
In Part A subjects receiving other concomitant medications, physical therapy, or other
treatments related to their current mTBI will be eligible if they meet the inclusion
criteria.
Subjects (or household members) who are not able to inject themselves or the subject will
be excluded.
For both Part A and Part B, subjects are not allowed to be concurrently enrolled in another
therapeutic intervention clinical trial while participating in this study. Any subjects
currently enrolled in such a separate therapeutic intervention clinical trial, for any
condition, will be excluded from participating in this study. For clarification, this does
not include observational clinical trials or registries.
Ultimately study subject participation will be at the discretion of the study physician.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo |
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. |
|
|
Experimental Ghrelin (OXE-103) |
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. |
|
More Details
- Status
- Completed
- Sponsor
- Michael Rippee, MD
Study Contact
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.