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

NCT00693121 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-10-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Amantadine hydrochloride

100mg administered orally twice daily x 14 days

DRUG

Placebo capsule

capsule, identical to amantadine hydrochloride capsule, administered twice daily x 14 days

Sponsors & Collaborators

  • U.S. Department of Education

    collaborator FED

  • Methodist Rehabilitation Center

    lead OTHER

Principal Investigators

  • Stuart A Yablon, M.D. · Brain Injury Program, Methodist Rehabilitation Center

  • Mark Sherer, Ph.D. · Department of Research, Memorial Hermann/TIRR, Houston, TX

  • Risa N Richardson, Ph.D. · Polytrauma Program, James A. Haley Veterans Hospital, Tampa, FL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2007-11-30
Completion
2019-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00693121 on ClinicalTrials.gov