NCT00970944 - Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI) | Biotech Hunter

Enrollment

184

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions

Traumatic Brain Injury

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.

Trial Locations (11)

10032

Columbia University, New York

12308

Sunnyview Rehabilitation Hospital, Schenectady

19027

Moss Rehabilitation Research Institute, Elkins Park

19355

Bryn Mawr Rehabilitation Hospital, Malvern

28203

Charlotte Rehabilitation Center, Charlotte

39216

Methodist Rehabilitation Center, Jackson

73450

Fachkrankenhaus Neresheim, Neresheim

78745

Texas NeuroRehabilitation Center, Austin

83043

Neurologische Klinik Bad Aibling, Bad Aibling

02184

Braintree Rehabilitation Hospital, Braintree

DK 2650

Hvidovre University Hospital, Hvidovre