Amantadine for Traumatic Brain Injury

Phase 2

Recruiting

Research Sponsored by SHINKEI Therapeutics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patient have sustained a trauma between 72 hours to 1 week

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 35

Summary

"This trial aims to determine if the treatment is safe and well-tolerated. Patients will be given either the MR-301 drug or a placebo and their outcomes will be compared, including neurological responses,

Who is the study for?

This trial is for adults aged 18-65 with severe traumatic brain injury (TBI) who were admitted to acute care within the past week and have a Glasgow Coma Score of 3-8. They must be unable to follow commands or communicate functionally, have at least one reactive pupil, stable vital signs, and TBI confirmed by imaging. A legal representative must consent.

What is being tested?

The study tests the safety of Amantadine Hydrochloride IV solution (MR-301) versus a placebo in patients with severe TBI. Over three weeks, participants will receive either MR-301 or a placebo twice daily while researchers monitor their overall outcome, neurological response, ICU/hospital stay duration, and mortality rates.

What are the potential side effects?

While specific side effects are not listed here, generally Amantadine can cause dizziness, blurred vision, dry mouth/nose/throat; constipation; loss of appetite; headache; sleep disturbances; mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been in the hospital for at least 2 days before joining the study.

Select...

I experienced a trauma between 3 days and 1 week ago.

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 35

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 35

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 35 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency, severity, and type of adverse events and serious adverse events between active treatment and placebo groups

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: MR-301Active Control1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

0 / 3Eligibility criteria met