Ghrelin (OXE--103) for Acute Concussion Management

NCT ID: NCT04558346

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2022-10-30

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.

Conditions

Concussion, Brain; Traumatic Brain Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

40ug/kg twice daily by self-injection

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.

Group Type: EXPERIMENTAL

Ghrelin (OXE-103)

Intervention Type: DRUG

40ug/kg twice daily by self-injection

Interventions

Ghrelin (OXE-103)

40ug/kg twice daily by self-injection

Intervention Type: DRUG

Placebo

40ug/kg twice daily by self-injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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 (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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Health System

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

Michael Rippee

OTHER

Sponsor Role: lead

Responsible Party

Michael Rippee

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Rippee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STUDY00145983

Identifier Type: -

Identifier Source: org_study_id