Study to Assess the Safety of Amantadine Hydrochloride (HCl) Intravenous (IV) Solution (MR-301) in Patients With Severe Traumatic Brain Injury (TBI).
Public ClinicalTrials.gov record NCT06253923. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06253923
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2024
- Primary completion
- Jul 30, 2025
- Completion
- Jul 31, 2025
- Last update posted
- Jul 14, 2025
2024 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| UF Health Heart and Vascular Hospital | Gainesville | Florida | 32608 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Hackensack Meridian Health Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | — |
| Department of Neurology, Duke University School of Medicine | Durham | North Carolina | 27705 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| McGovern Medical School, University of Texas Health Science Center | Houston | Texas | 77030 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06253923, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2025 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06253923 live on ClinicalTrials.gov.