Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00800514

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will explore the neurocognitive effect of four weeks of treatment with amantadine versus placebo in patients with traumatic brain injury using the Interval Bisection Timing Task. Approximately 16 individuals with traumatic brain injury are expected to participate in this study. Subject participation is expected to last up to 8 weeks with 16 study visits.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Drug: amantadine Drug: amantadine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: active	Drug: amantadine amantadine twice daily Drug: amantadine amantadine 100 mg twice daily

Arm

Intervention/Treatment

Experimental: active

Drug: amantadine

amantadine twice daily

Drug: amantadine

amantadine 100 mg twice daily

Outcome Measures

Primary Outcome Measures

The primary outcome measure is the Interval Bisection Timing Task. [12 -16 months]

Secondary Outcome Measures

The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). [12-16 moths]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 to 55 inclusive. History of post-MVA close head TBI. Female subjects must use an acceptable method of contraception during entire study. Acceptable methods of contraception are: history of surgical sterility, postmenopausal status, hormonal contraceptives, or accepted barrier devices (i.e., male/female condom, diaphragm, cervical cap, intrauterine device).

Exclusion Criteria:

Current or past history of major psychiatric disorder (schizophrenia, bipolar disorder, major depressive disorder)
Substance use disorder
Current or past history of serious chronic medical condition (pulmonary (lung), cardiovascular (heart), hepato-renal (liver-kidney) disease, diabetes)
Seizures
Smoking one or more packs of cigarettes per day
If you are pregnant or breastfeeding, or plan to become pregnant during the study