ACTIVE_NOT_RECRUITING

Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Multicenter, Double-blind, Randomized, Placebo Controlled, Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301), in Patients With Severe Traumatic Brain Injury (TBI).

Quick Facts

Study Start:2024-06-01

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06253923

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age: 18 to 75 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)\].	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. 11. Patient has a history of NYHA Class 3 or Class 4 Congestive Heart Failure within the last 5 years. 12. Females who are nursing, pregnant, or planning to become pregnant 13. any other clinically significant medical condition as determined by the Investigator, that may unfavorably alter the risk benefit of study participation. 14. Patient has prolonged QT interval. 15. Treatment with a systemic anticholinergic medication within 1 week prior to screening.

Inclusion Criteria

Exclusion Criteria

1. Age: 18 to 75 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)\].

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.
11. Patient has a history of NYHA Class 3 or Class 4 Congestive Heart Failure within the last 5 years.
12. Females who are nursing, pregnant, or planning to become pregnant
13. any other clinically significant medical condition as determined by the Investigator, that may unfavorably alter the risk benefit of study participation.
14. Patient has prolonged QT interval.
15. Treatment with a systemic anticholinergic medication within 1 week prior to screening.

Contacts and Locations

Study Locations (Sites)

Los Angeles General Medical Center

Los Angeles, California, 90033

United States

UC Davis Medical Center

Sacramento, California, 95817

United States

UF Health Heart and Vascular Hospital

Gainesville, Florida, 32608

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

Maine Medical Center

Portland, Maine, 04102

United States

Wayne State University

Detroit, Michigan, 48201

United States

Barnes Jewish Hospital

Saint Louis, Missouri, 63110

United States

Hackensack Meridian Health Jersey Shore University Medical Center

Neptune, New Jersey, 07753

United States

University of New Mexico Hospital

Albuquerque, New Mexico, 87106

United States

Department of Neurology, Duke University School of Medicine

Durham, North Carolina, 27705

United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104

United States

McGovern Medical School, University of Texas Health Science Center

Houston, Texas, 77030

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: SHINKEI Therapeutics, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-01

Study Completion Date2025-08

Study Record Updates

Study Start Date2024-06-01

Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

Traumatic Brain Injury