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SHINKEI - TBI

  • Status
    Accepting Candidates
  • Age
    18 Years - 65 Years
  • Sexes
    All
  • Healthy Volunteers
    No

Objective

The main goal of this clinical trial is to check if the treatment is safe and well-tolerated. Researchers will compare the MR-301 active drug group with the placebo group to evaluate the safety and tolerability of the drug. Other measurements include assessing the patient's overall outcome, neurological responses, time spent in the intensive care unit, time in the hospital, and mortality. Participants will receive either MR-301 BID IV dosing or a matching placebo for a total of 3 weeks.

Description

This is a multi-center, randomized, placebo-controlled study of MR-301 administered BID IV in patients with severe TBI.

Participant: 45 patients with severe Tbi who maintain Gcs scores 3-8 both inclusive.

Intervention: Mr-301 or placebo will be administered intravenously Bid for upto 3 weeks.

Primary Outcome: Safety and Tolerability of Mr-301

Secondary Outcome: Gos-E, Crs-R, Drs, Four score, time to Icu discharge, time to hospital discharge and mortality.

Details

Full study title A Phase 2, multicenter, double-blind, randomized, placebo-controlled, study to assess the safety of amantadine hydrochloride (HCl) intravenous (IV) solution (MR-301), 50 mg/mL, in patients with severe traumatic brain injury (TBI).
Protocol number OCR45240
ClinicalTrials.gov ID NCT06253923
Phase Phase 2

Eligibility

Inclusion Criteria:

  1. Age: 18 to 65 years.

  2. Patients with TBI confirmed by CT scan or MRI

  3. Patient have sustained a trauma between 72 hours to 1 week

  4. Patient with Abbreviated Injury Score (AIS) ≤ 2.

  5. Patients must be admitted to an acute care setting no less than 2 days prior to randomization.

  6. Glasgow Coma Score of 3 to 8, inclusive.

  7. Patients must be unable to consistently follow commands or to engage in functional communication, as assessed by the score on the CRS-R.

  8. Patients have at least one reactive pupil.

  9. Must have a Legally Authorized Representative (LAR) able to provide consent for the trial.

  10. Patient must have stable vitals ---Intracranial pressure ICP Value is at discretion

of investigator), systolic blood pressure (SBP>90 mmHg) partial pressure of oxygen

(PaO2 > 60 mmHg)].

Exclusion Criteria:

  1. Life expectancy of less than 24 hours.

  2. Patient has any spinal cord injury.

  3. Patient has a penetrating head injury.

  4. Patient has bilaterally fixed dilated pupils

  5. Patients with history of any medical or psychiatric disorder, or any severe concomitant disease that would, in the opinion of the Investigator, interfere with clinical assessment.

  6. Patient has poorly controlled seizure more than one per month.

  7. Prior history of status epilepticus

  8. Prior treatment with or a sensitivity to amantadine HCl or amantadine.

  9. Patient has screening lab measurements outside the normal range

    1. Absolute neutrophil count (ANC): ≤ 1. 5 x 109/L

    2. Hemoglobin ≤ 8 g/dL or active bleeding requiring ongoing transfusions.

    3. Platelets ≤ 80 x 109/L or active bleeding requiring ongoing transfusions.

    4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total bilirubin (unless isolated Gilbert's syndrome) ≥ 2x the upper limit of normal (ULN)

    5. Estimated glomerular filtration rate (eGFR) < 60 ml/min/1. 73m2

  10. Patient has received treatment with an investigational drug, CNS stimulant or

dopamine antagonist/agonist within 4 weeks.

  1. Patient has a history of NYHA Class 3 or Class 4 Congestive Heart Failure within the

last 5 years.

  1. Females who are nursing, pregnant, or planning to become pregnant

  2. any other clinically significant medical condition as determined by the

Investigator, that may unfavorably alter the risk benefit of study participation.

  1. Patient has prolonged QT interval.

  2. Treatment with a systemic anticholinergic medication within 1 week prior to

screening.

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.