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

Not Applicable

Withdrawn

• Conditions: Traumatic Brain Injury
• Interventions: Drug: amantadine

• Registration Number: NCT00800514
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-01
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Study Start: 2009-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
active	amantadine	-

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the Interval Bisection Timing Task.	12 -16 months

Secondary Outcome Measures

Name	Time	Method
The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11).	12-16 moths

Trial Locations

Locations (1)

CHS-Behavioral Health Research; 🇺🇸 Charlotte, North Carolina, United States