Amantadine for Traumatic Brain Injury
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: SHINKEI Therapeutics, Inc
Must not be taking: Amantadine, CNS stimulants, others
Disqualifiers: Spinal cord injury, Seizures, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop all current medications, but you cannot have taken an investigational drug, CNS stimulant, dopamine antagonist/agonist within 4 weeks, or a systemic anticholinergic medication within 1 week before screening.
What data supports the effectiveness of the drug amantadine for traumatic brain injury?
Is amantadine generally safe for humans?
Amantadine has been studied for various conditions, including Parkinson's disease and autism, and is generally considered safe. In studies, side effects were similar to placebo, with mild cases of skin discoloration and blurred vision reported. In a study on traumatic brain injury, no side effects were observed.678910
How is the drug amantadine different from other treatments for traumatic brain injury?
Research Team
Eligibility Criteria
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.Inclusion Criteria
I have someone legally authorized to make decisions for me.
I have been in the hospital for at least 2 days before joining the study.
I experienced a trauma between 3 days and 1 week ago.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive MR-301 or placebo intravenously BID for up to 3 weeks
3 weeks
Daily visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
2 weeks
2 visits (in-person)
Treatment Details
Interventions
- Amantadine Hydrochloride (Anti-viral agent)
Trial OverviewThe 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.
Participant Groups
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
Amantadine Hydrochloride is already approved in United States, European Union, Canada for the following indications:
πΊπΈ Approved in United States as Gocovri for:
- Dyskinesia associated with Parkinson's disease
- Influenza A viral infection
πͺπΊ Approved in European Union as Symmetrel for:
- Parkinson's disease
- Extrapyramidal side effects of medications
- Postherpetic neuralgia
π¨π¦ Approved in Canada as Amantadine Hydrochloride for:
- Parkinson's disease
- Influenza A viral infection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Maine Medical CenterPortland, ME
University of New Mexico HospitalAlbuquerque, NM
Medical College of WisconsinMilwaukee, WI
UF Health Heart and Vascular HospitalGainesville, FL
More Trial Locations
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Who Is Running the Clinical Trial?
SHINKEI Therapeutics, Inc
Lead Sponsor
Trials
1
Patients Recruited
50+
Duke Clinical Research Institute
Collaborator
Trials
69
Patients Recruited
242,000+
References
Placebo-controlled trial of amantadine for severe traumatic brain injury. [2022]Amantadine hydrochloride is one of the most commonly prescribed medications for patients with prolonged disorders of consciousness after traumatic brain injury. Preliminary studies have suggested that amantadine may promote functional recovery.
A placebo-controlled randomized clinical trial of amantadine hydrochloride for evaluating the functional improvement of patients following severe acute traumatic brain injury. [2023]Considering the known derangements in the dopaminergic neurotransmitter systems following traumatic brain injury (TBI), dopamine agonists are used as a pharmacologic option. In this study, we evaluate the effects of amantadine hydrochloride on the functional improvement of severe TBI patients.
Amantadine to Treat Cognitive Dysfunction in Moderate to Severe Traumatic Brain Injury. [2017]Traumatic brain injury (TBI) is a leading cause of injury, disability, and death in the United States. Amantadine is an established dopamine agonist that supports neurological function. The purpose of this literature review was to determine whether amantadine improves cognitive function post-TBI. PubMed and CINAHL were used to search the literature for articles using amantadine to treat TBI from 1994 to 2004. Outcomes were summarized and the evidence was appraised. Although earlier studies from 1994 to 2003 were lower-level studies and recommended further research on treatment of cognitive dysfunction in TBI, the literature from 2004 to present generally concluded that amantadine improved cognitive function related to arousal, memory, and aggression. It can be started days to months postinjury and still produces benefits.
Effects of the dopaminergic agent and NMDA receptor antagonist amantadine on cognitive function, cerebral glucose metabolism and D2 receptor availability in chronic traumatic brain injury: a study using positron emission tomography (PET). [2022]This study was performed to assess effects of amantadine (AMH), a dopaminergic agent and NMDA antagonist, on chronic traumatic brain injury (TBI). The primary hypotheses were that amantadine treatment would result in executive function improvement and increased activity in pre-frontal cortex.
The effect of amantadine on acute cognitive disability after severe traumatic brain injury: An institutional pilot study. [2023]Amantadine is used in the post-acute care setting to improve cognitive function after a traumatic brain injury. Its utility in the acute postinjury period is unknown. In this pilot study, we sought to examine the effect of amantadine on short-term cognitive disability among patients with a severe traumatic brain injury and hypothesized that patients receiving amantadine would have a greater improvement in disability throughout their acute hospitalization.
Amantadine and a fixed combination of levodopa and carbidopa in the treatment of Parkinson's disease. [2013]Forty-two patients with Parkinson's disease were given amantadine HC1 (Symmetrel) and placebo in an 18 week double-blind cross-over study to determine if amantadine provided additional benefit when combined with levodopa and carbidopa (Sinemet). Analysis of our results showed that amantadine effected a 92% improvement over baseline in symptom scores and a 95% improvement over baseline in activity impairment scores, compared with corresponding values of 4% and 18% for placebo. The difference between amantadine and placebo was statistically significant. Except for one case of mild livedo reticularis and two of blurred vision in the amantadine group, side effects were generally similar for amantadine and placebo in type and frequency. This study provides new evidence of the importance of combinations of antiparkinson drugs to achieve maximum therapeutic benefit.
Double-blind, placebo-controlled study of amantadine hydrochloride in the treatment of children with autistic disorder. [2013]To test the hypothesis that amantadine hydrochloride is a safe and effective treatment for behavioral disturbances--for example, hyperactivity and irritability--in children with autism.
Amantadine for levodopa resistant parkinsonism. [2019]A 65-year-old woman with stigmata of Parkinsonism was resistant to therapy with levodopa, bromocriptine and anticholinergics. However, administration of amantadine (Symmetrel), (200 mg/day) produced significant improvement in her motor disability as well as in her mental status. The mechanisms of amantadine's therapeutic effects in this unusual case are discussed.
N of 1 study: amantadine for the amotivational syndrome in a patient with traumatic brain injury. [2019]Severe amotivation, apathy, and abulia, significantly retard rehabilitation following traumatic brain injury. Preliminary, uncontrolled research has suggested possible benefit with amantadine for this behavioural syndrome. This N of 1, double-blind, placebo-controlled study employed amantadine 100 mg three times daily in one such patient. Therapists and nurses completed inventories scoring efforts towards initiation of therapeutic activities during each session, progress in therapy, and participation in therapy. Four treatment periods (two active medication, two placebo), of 2 weeks duration, were completed. Across four therapists, and for both treatment pairs, the average effect score increased from 0.86 on placebo to 1.74 on amantadine (possible range 0-6, 3 = 'average'). There were no side-effects. The study suggests possible benefit with amantadine for patients with amotivational syndrome after traumatic brain injury; a randomized clinical trial appears warranted and required.
Amantadine for traumatic brain injury: does it improve cognition and reduce agitation? [2013]To review the available literature pertaining to amantadine as therapy for improving cognition and reducing agitation following a non-penetrating traumatic brain injury (TBI).
Amantadine for patients with severe traumatic brain injury: a critically appraised topic. [2022]Research into traumatic brain injury (TBI) has increased significantly. Diagnostic testing and therapeutics for patients with severe TBI are 2 areas on which there is increasing focus. Amantadine hydrochloride is one treatment considered to have potential therapeutic value in this patient population.
The effects of amantadine on traumatic brain injury outcome: a double-blind, randomized, controlled, clinical trial. [2019]Amantadine, as a dopamine receptor agonist, may stimulate and help the recovery of the nervous system after traumatic brain injury (TBI).