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Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI)

NCT00970944 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2012-09-24

Study results available
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Summary

This is a controlled trial of amantadine to improve level of function following severe traumatic brain injury.

The purpose of this study is:

1. To determine whether amantadine hydrochloride, given in a dose of 200-400 mg, improves functional recovery from the vegetative and minimally conscious states
2. To determine whether amantadine-related gains in function persist following drug discontinuation
3. To determine the safety profile of amantadine in patients with disorders of consciousness

Conditions

Interventions

DRUG

Amantadine Hydrochloride

184 patients who remain in VS or MCS 4 - 16 weeks post-TBI will be randomized in a stratified fashion to 4 weeks of amantadine (200 - 400 mg/day) followed by a 2-week washout period. The Disability Rating Scale (DRS) will be the primary dependent variable with the Coma Recovery Scale-Revised (CRS-R) serving as a supplementary measure.

DRUG

Placebo

Placebo administered twice daily.

Sponsors & Collaborators

  • U.S. Department of Education

    collaborator FED

  • JFK Medical Center

    lead OTHER

Principal Investigators

  • Joseph T. Giacino, Ph.D. · Spaulding Rehabilitation Hospital

  • John Whyte, MD, Ph.D. · Moss Rehabilitation Research Institute

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
2003-02-28
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Denmark
  • Germany

Study Locations

More Related Trials

Entities

Drugs
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 NCT00970944 on ClinicalTrials.gov