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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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active

Group Type EXPERIMENTAL

amantadine

Intervention Type DRUG

amantadine twice daily

amantadine

Intervention Type DRUG

amantadine 100 mg twice daily

Interventions

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amantadine

amantadine twice daily

Intervention Type DRUG

amantadine

amantadine 100 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No