Ghrelin (OXE--103) for Acute Concussion Management
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|ClinicalTrials.gov Identifier: NCT04558346|
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : January 25, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Concussion, Brain Traumatic Brain Injury||Drug: Ghrelin (OXE-103) Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ghrelin (OXE--103) for Acute Concussion Management|
|Actual Study Start Date :||October 20, 2020|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
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.
40ug/kg twice daily by self-injection
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.
Drug: Ghrelin (OXE-103)
40ug/kg twice daily by self-injection
- Symptom Management - Post Concussion Symptom Scale [ Time Frame: Days 1-44 ]
The primary goal is to describe the change in number of symptoms and/or severity of symptoms in sub-acute concussion with treatment with OXE-103 using the Post Concussion Symptom Scale questionnaire during the intervention period at days 1 and 15 as well as during the post-treatment period at days 21 and 44.
The Post Concussion Symptom Scale questionnaire consists of 23 common concussion symptoms which are assigned a ranking of severity on a scale from 0 (no symptom) to 6 (severe symptom). This tool is used to capture both severity of concussion symptoms as well as the number of symptoms.
- Quality of Life - QOLIBRI-OS [ Time Frame: Days 1-44 ]
A secondary goal is to examine change in quality of life with treatment of sub-acute concussion using the Quality of Life after Brain Injury - Overall Scale questionnaire.
The Quality of Life after Brain Injury - Overall Scale questionnaire consists of six questions which address satisfaction of life after injury. Responses are assigned a ranking on a scale from "not at all" to "very."
- Quality of Life - PGAS [ Time Frame: Days 1-44 ]A secondary goal is to examine change in quality of life with treatment of sub-acute concussion using a Patient Global Assessment Scale, which is measured using a visual analogue scale. The range is from 0 (no impact) to 10 (greatest impact). This tool asks how concussion symptoms impact ability to function or perform daily activities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558346
|Contact: Jamie Chen||913-945-9542||ConcussionResearch@kumc.edu|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Jamie Chen 913-945-9542 ConcussionResearch@kumc.edu|
|Principal Investigator: Michael Rippee, MD|
|Principal Investigator:||Michael Rippee, MD||University of Kansas Medical Center|