Ghrelin (OXE--103) for Acute Concussion Management

Phase 2

Completed

• Conditions: Concussion, Brain; Traumatic Brain Injury
• Interventions: Drug: Placebo; Drug: Ghrelin (OXE-103)

• Registration Number: NCT04558346
• Lead Sponsor: Michael Rippee

Brief 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 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.

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-22
• Study Start: 2020-10-20
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Results First Submitted: 2024-03-27
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Results First Posted: 2024-05-21
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Ghrelin (OXE-103)	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.

Primary Outcome Measures

Name	Time	Method
Symptom Management - Post Concussion Symptom Scale	Days 1, 15, and 44	The primary goal is to describe the change in 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 day 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. Data will be reported with the total values of all 23 subscale symptoms (total score = sum of all subscale symptom scores)--total can range from 0 to 138 with lower scores indicating lower symptom burden and higher scores a higher symptom burden (lower score = better outcome)

Secondary Outcome Measures

Name	Time	Method
Quality of Life - QOLIBRI-OS	Days 1, 15, and 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 The QOLIBRI scores are reported on a 0-100 scale , where 0=worst possible quality of life and 100=best possible quality of life.; Responses to the 'satisfaction' items (i.e. items on the Cognition, Self, Daily Life \& Autonomy, and Social Relationships scales) are on a 1-5 scale, 1= "not at all satisfied" and 5="very satisfied". Responses to the 'bothered' items (i.e. items on the Emotions and Physical Problems scales) are reverse scored to correspond with the satisfaction items, where 1="very bothered" and 5="not at all bothered".; The responses on each scale are summed to give a total, and then divided by the number of responses to give a scale mean. The scale means have a maximum possible range of 1 to 5. In a similar manner the QOLIBRI Total score is calculated by summing all the responses, and then dividing by the actual number of responses.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States