Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State

October 17, 2023 updated by: Methodist Rehabilitation Center

Amantadine Hydrochloride for Treatment of Symptoms of the Post-traumatic Confusional State Among Neurorehabilitation Admissions With TBI: A Randomized, Double-Blind, Placebo-Controlled Trial

Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, patients may pose increased risk of injury to themselves or others during this period. Their behavior may also increase stress for family members and interfere with their ability to benefit from rehabilitation therapies. A number of different medications have been used to treat confusion to decrease agitation, decrease risk of injury, and improve participation in rehabilitation therapies. To this point, there has not been a research or scientific basis for knowing which medication is the best for a specific patient. The overall goal of this study is to conduct a scientific investigation to help determine which medication works best to treat confusion.

Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute confusion after traumatic brain injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with TBI who require inpatient rehabilitation are frequently confused at the time of admission for rehabilitation. Our investigations of confusion conducted as part of the TBIMSM have clarified the nature of confusion in early recovery after TBI. Early confusion (PTCS) has been found to be a complex syndrome characterized by disorientation, cognitive impairment, restlessness, decreased level of daytime arousal, sleep disturbance, fluctuation of symptoms, and psychotic-type symptoms. PTCS complicates early management of patients with TBI, and may contribute to increased risk of injury to patients and hospital staff, increased stress among family members and staff, decreased participation in therapies, increased cost of care, and an increased likelihood of being discharged to psychiatric or long-term care settings. These facts indicate the need for effective management of PTCS. Consensus regarding optimal treatment of the cognitive and behavioral symptoms encountered among patients with PTCS does not exist currently. While many agents have been tried to address such symptoms in TBI, few have been investigated systematically. These circumstances indicate the need for appropriate clinical trials to provide guidance to clinicians for medical treatment of PTCS. In response, the NIDRR-Traumatic Brain Injury Model System of Mississippi proposed a randomized, double-blinded, placebo-controlled, parallel group trial for the pharmacological treatment of PTCS. The agent selected for this clinical trial is amantadine, an NMDA and indirect dopamine agonist. This agent will be compared to placebo on response measures of efficacy and safety.

Study hypothesis: Amantadine will reduce the severity and number of symptoms of PTCS.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Methodist Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acute Traumatic Brain Injury (≤90 days postinjury)
  • Responsive (not fulfilling criteria for Minimally Conscious State)
  • Meet PTCS criteria on 2 consecutive examinations (as determined by the Confusion Assessment Protocol)
  • Initial neurorehabilitation hospital admission
  • Anticipated ≥2 week length-of-stay after meeting PTCS criteria

Exclusion Criteria:

  • Preexisting seizure disorder
  • Prior history of hospitalization for psychiatric condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Identical capsule to amantadine hydrochloride active intervention, administered twice daily x 14 days
Drug: Placebo capsule
capsule, identical to amantadine hydrochloride capsule, administered twice daily x 14 days
Active Comparator: Amantadine
Amantadine hydrochloride 100mg capsule administered twice daily x 14 days
Drug: Amantadine hydrochloride
100mg administered orally twice daily x 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Confusion Assessment Protocol (number of symptoms)
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
number of participants withdrawn from study due to fulfillment of "escape criteria"
Time Frame: 14 days
14 days
Time to reach "non-confused" Confusion Assessment Protocol score
Time Frame: <14 days
<14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Rehabilitation Center

Collaborators

U.S. Department of Education

Investigators

  • Principal Investigator: Stuart A Yablon, M.D., Brain Injury Program, Methodist Rehabilitation Center
  • Study Director: Mark Sherer, Ph.D., Department of Research, Memorial Hermann/TIRR, Houston, TX
  • Study Director: Risa N Richardson, Ph.D., Polytrauma Program, James A. Haley Veterans Hospital, Tampa, FL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimated)

June 6, 2008

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MethodistRC Project 1
  • NIDRR grant #: H133A020514

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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