Traumatic Brain InjuryPhase 2NCT06253923
Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).
A Phase 2 study testing Amantadine Hydrochloride in people with Traumatic Brain Injury, run by SHINKEI Therapeutics, Inc at 13 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Amantadine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Jun 2024to Aug 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 75 years.
- Patients with TBI confirmed by CT scan or MRI
- Patient have sustained a trauma between 72 hours to 1 week
- Patient with Abbreviated Injury Score (AIS) ≤ 2.
- Patients must be admitted to an acute care setting no less than 2 days prior to randomization.
- Glasgow Coma Score of 3 to 8, inclusive.
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- Patients must be unable to consistently follow commands or to engage in functional communication, as assessed by the score on the CRS-R.
- Patients have at least one reactive pupil.
- Must have a Legally Authorized Representative (LAR) able to provide consent for the trial.
- 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)].
Who cannot join
- Life expectancy of less than 24 hours.
- Patient has any spinal cord injury.
- Patient has a penetrating head injury.
- Patient has bilaterally fixed dilated pupils
- 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.
- Patient has poorly controlled seizure more than one per month.
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- Prior history of status epilepticus
- Prior treatment with or a sensitivity to amantadine HCl or amantadine.
- Patient has screening lab measurements outside the normal range
- Absolute neutrophil count (ANC): ≤ 1.5 x 109/L
- Hemoglobin ≤ 8 g/dL or active bleeding requiring ongoing transfusions.
- Platelets ≤ 80 x 109/L or active bleeding requiring ongoing transfusions.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) or total bilirubin (unless isolated Gilbert's syndrome) ≥ 2x the upper limit of normal (ULN)
- Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73m2
- Patient has received treatment with an investigational drug, CNS stimulant or dopamine antagonist/agonist within 4 weeks.
- Patient has a history of NYHA Class 3 or Class 4 Congestive Heart Failure within the last 5 years.
- Females who are nursing, pregnant, or planning to become pregnant
- any other clinically significant medical condition as determined by the Investigator, that may unfavorably alter the risk benefit of study participation.
- Patient has prolonged QT interval.
- Treatment with a systemic anticholinergic medication within 1 week prior to screening.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of New Mexico Hospital
Albuquerque, New Mexico, 87106
Wayne State University
Detroit, Michigan, 48201
Department of Neurology, Duke University School of Medicine
Durham, North Carolina, 27705
UF Health Heart and Vascular Hospital
Gainesville, Florida, 32608
McGovern Medical School, University of Texas Health Science Center
Houston, Texas, 77030
Los Angeles General Medical Center
Los Angeles, California, 90033
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hackensack Meridian Health Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
UC Davis Medical Center
Sacramento, California, 95817
Barnes Jewish Hospital
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
About this study
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).
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.
Read the detailed 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Amantadine Hydrochloride, Placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amantadine HydrochlorideDrug
MR-301 is an I.V. formulation for the treatment of TBI. The active ingredient is amantadine hydrochloride (HCl).
PlaceboDrug
The placebo for this study is 0.9% Sodium Chloride IV Solution.
| Study group | Role | What they receive |
|---|---|---|
| MR-301 | Active comparator | On first day, patient will receive MR-301 at 100 mg intravenous infusion BID. On second day, the dose is elevated to 150 mg intravenous infusion BID.
On third day, the dose is further elevated to 200 mg intravenous infusion BID and maintained up to Day 21 Receives: Drug: Amantadine Hydrochloride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, severity, and type of adverse events and serious adverse events between active treatment and placebo groups
Safety and tolerability will be compared between active treatment and placebo groups.
Measured: Day 1 to Day 35
Secondary outcomes (8)
Change from baseline in Glasgow Outcome Scale-Extended
Measured: Day 21 and Day 35
Change from baseline in Disability Rating Scale (DRS) scale
Measured: Day 5, Day 10, Day 15, Day 21
Change from baseline in Coma Recovery Scale - Revised
Measured: Day 5, Day 10, Day 15, Day 21
Change from baseline in Full Outline of UnResponsiveness (FOUR) score
Measured: every day up to Day 21
Time to intensive care unit (ICU) discharge to hospital floor
Measured: up to day 21
Time to hospital discharge from randomization
Measured: up to day 21
Mortality assessment at end of treatment period
Measured: Day 21
Mortality assessment at end of study period (Day 35).
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start1 Jun 2024
- Primary completion31 Jul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SHINKEI Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253923
- Sponsor's protocol ID
- MR-301-T-001
- Status last verified
- Jul 2025
- First submitted
- 2 Feb 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06253923
- Acronym / sponsor ID
- MR-301-T-001
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- SHINKEI Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MR-301 | Active comparator | Drug: Amantadine HydrochlorideOn first day, patient will receive MR-301 at 100 mg intravenous infusion BID. On second day, the dose is elevated to 150 mg intravenous infusion BID. On third day, the dose is further elevated to 200 mg intravenous infusion BID and maintained up to Day 21 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18 to 75 years.
- Patients with TBI confirmed by CT scan or MRI
- Patient have sustained a trauma between 72 hours to 1 week
- Patient with Abbreviated Injury Score (AIS) ≤ 2.
- Patients must be admitted to an acute care setting no less than 2 days prior to randomization.
Key exclusion criteria (20 listed)
- Life expectancy of less than 24 hours.
- Patient has any spinal cord injury.
- Patient has a penetrating head injury.
- Patient has bilaterally fixed dilated pupils
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amantadine HydrochlorideMR-301 is an I.V. formulation for the treatment of TBI. The active ingredient is amantadine hydrochloride (HCl). | Drug | MR-301 |
| PlaceboThe placebo for this study is 0.9% Sodium Chloride IV Solution. | Drug | Placebo |
Primary outcome
Frequency, severity, and type of adverse events and serious adverse events between active treatment and placebo groups
Time frame: Day 1 to Day 35
Safety and tolerability will be compared between active treatment and placebo groups.
8 secondary outcomes
Change from baseline in Glasgow Outcome Scale-Extended
Time frame: Day 21 and Day 35
Change from baseline in Disability Rating Scale (DRS) scale
Time frame: Day 5, Day 10, Day 15, Day 21
Change from baseline in Coma Recovery Scale - Revised
Time frame: Day 5, Day 10, Day 15, Day 21
Change from baseline in Full Outline of UnResponsiveness (FOUR) score
Time frame: every day up to Day 21
Time to intensive care unit (ICU) discharge to hospital floor
Time frame: up to day 21
Time to hospital discharge from randomization
Time frame: up to day 21
Mortality assessment at end of treatment period
Time frame: Day 21
Mortality assessment at end of study period (Day 35).
Time frame: Day 35
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amantadine Hydrochloride in people with Traumatic Brain Injury, run by SHINKEI Therapeutics, Inc at 13 sites 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 10 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Frequency, severity, and type of adverse events and serious adverse events between active treatment and placebo groups (time frame: Day 1 to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.