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Amantadine for the Treatment of Traumatic Brain Injury Irritability and Aggression: A Multi-site Study

NCT00779324 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2022-07-12

Study results available
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Summary

The purpose of this study is to study the effect of amantadine on irritability and aggression caused by traumatic brain injury.

Conditions

  • Brain Injury
  • Aggression

Interventions

DRUG

Amantadine Hydrochloride

100 mg every morning and noon

DRUG

Placebo

one placebo tablet every morning and 12 Noon

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • The Institute for Rehabilitaion and Research Foundation

    collaborator OTHER

  • Spaulding Rehabilitation Hospital

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Flora M Hammond, MD · Carolinas Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00779324 on ClinicalTrials.gov