Ghrelin (OXE--103) for Acute Concussion Management

NCT04558346 | Completed Phase 2 Results FDA Drug

• 1 other identifier: STUDY00145983
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Symptom Management - Post Concussion Symptom Scale

  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)

  Days 1, 15, and 44

Secondary Outcomes (1)

• Quality of Life - QOLIBRI-OS

  Days 1, 15, and 44

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Ghrelin (OXE-103)

EXPERIMENTAL

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)

Interventions

Ghrelin (OXE-103) DRUG

40ug/kg twice daily by self-injection

Ghrelin (OXE-103)

Placebo DRUG

40ug/kg twice daily by self-injection

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Michael Rippee: lead
• University of Kansas Health System: collaborator
• University of Kansas Medical Center: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Interventions

Ghrelin

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Michael Rippee
• Organization: University of Kansas Medical Center

mrippee@kumc.edu

913-945-7486

Study Officials

• Michael Rippee, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 22, 2020
• Study Start: October 20, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: May 21, 2024
• Results First Posted: May 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)