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 Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
INCLUSION AND EXCLUSION:
Subjects must be consented within 28 days post injury.
Subjects 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 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.
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.
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
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
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
Study Contact
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.