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Concussion, BrainPhase 2NCT04558346

Ghrelin (OXE--103) for Acute Concussion Management

A Phase 2 study testing Ghrelin (OXE-103) in people with Concussion, Brain and Traumatic Brain Injury, run by Michael Rippee at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Concussion, Brain, Traumatic Brain Injury
What is being tested?
Ghrelin (OXE-103)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteUnited States
Study dates
20 Oct 2020to 30 Oct 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

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.

Read more

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.

Read the 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.

Being tested
Ghrelin (OXE-103), Placebo
Medical subject headings
Brain Concussion, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ghrelin (OXE-103)Drug

    40ug/kg twice daily by self-injection

  • PlaceboDrug

    40ug/kg twice daily by self-injection

Study groups in NCT04558346
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo (40ug/kg) will be self-administered twice daily for 14 days. ONLY THE PART B (ACUTE) SUBJECTS WILL BE RANDOMIZED AND MAY RECEIVE PLACEBO.
Receives: Drug: Placebo
Ghrelin (OXE-103)ExperimentalOXE-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.
Receives: Drug: Ghrelin (OXE-103)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Days 1, 15, and 44

Secondary outcomes (1)

  1. Quality of Life - QOLIBRI-OS

    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.

    Measured: Days 1, 15, and 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start20 Oct 2020
  3. Primary completion30 Oct 2022
  4. Study completion30 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04558346
Sponsor's protocol ID
STUDY00145983
Status last verified
Apr 2024
First submitted
3 Sep 2020
Last updated
21 May 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ghrelin (OXE-103) in people with Concussion, Brain and Traumatic Brain Injury, run by Michael Rippee at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Management - Post Concussion Symptom Scale (time frame: Days 1, 15, and 44). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04558346.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.

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