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NCT06253923 · ClinicalTrials.gov registry record · Phase 2
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 of Traumatic Brain Injury, sponsored by SHINKEI Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 13
- Study locations
NCT06253923: Active Phase 2 study of Traumatic Brain Injury, sponsored by SHINKEI Therapeutics.
NCT06253923 is a Phase 2 study of Traumatic Brain Injury that is active but no longer recruiting, run by SHINKEI Therapeutics. The registered enrollment target is 45 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (84% lower). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06253923, a Phase 2 study of Traumatic Brain Injury, is active but no longer recruiting, sponsored by SHINKEI Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 13
- Study locations
Study 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. 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.
Primary Outcome
Safety and tolerability will be compared between active treatment and placebo groups.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Amantadine Hydrochloride
Study Locations (13)
California
- Los Angeles General Medical Center - Los Angeles
- UC Davis Medical Center - Sacramento
Florida
- UF Health Heart and Vascular Hospital - Gainesville
- Tampa General Hospital - Tampa
Maine
- Maine Medical Center - Portland
Michigan
- Wayne State University - Detroit
Missouri
- Barnes Jewish Hospital - St Louis
New Jersey
- Hackensack Meridian Health Jersey Shore University Medical Center - Neptune City
New Mexico
- University of New Mexico Hospital - Albuquerque
North Carolina
- Department of Neurology, Duke University School of Medicine - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2025-08 |
| Phase | Phase 2 |
What the registry record for NCT06253923 still lists
NCT06253923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06253923 lists 13 locations in 11 states (California, Florida, Maine).
Frequently Asked Questions
What is clinical trial NCT06253923 about?
NCT06253923 is a clinical study titled "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, neurolog...
What is the current status of trial NCT06253923?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2024-06-01. Estimated completion is 2025-08.
What conditions does trial NCT06253923 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT06253923?
The interventions under investigation include: Placebo (DRUG), Amantadine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT06253923?
This trial is sponsored by SHINKEI Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06253923 being conducted?
This trial has 13 study locations across California, Florida, Maine, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Traumatic Brain Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06253923's enrollment target sits among peer trials
45 125th of 171 higher than 45 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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