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NCT00800514 Clinical Trial

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

Traumatic Brain Injury Clinical Trial

Official title:
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00800514
Other study ID # 08-01
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2009
Est. completion date November 2010

Study information
Verified date February 2022
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• amantadine
amantadine twice daily
• amantadine
amantadine 100 mg twice daily

Locations
Country Name City State
United States CHS-Behavioral Health Research Charlotte North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary outcome measure is the Interval Bisection Timing Task. 12 -16 months
Secondary The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). 12-16 moths
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