Back to resultsAmantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)
Primary Purpose
Traumatic Brain Injury
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
amantadine
amantadine
Sponsored by
About this trial
This is an interventional basic science trial for Traumatic Brain Injury focused on measuring perception of time, traumatic brain injury, amantadine
Eligibility Criteria
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
Sites / Locations
- CHS-Behavioral Health Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
active
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome measure is the Interval Bisection Timing Task.
Secondary Outcome Measures
The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11).
Full Information
NCT ID
NCT00800514
First Posted
December 1, 2008
Last Updated
April 20, 2022
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00800514
Brief Title
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)
Official Title
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Principal investigator took a position at another institution. No subjects enrolled.
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
perception of time, traumatic brain injury, amantadine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
amantadine
Intervention Description
amantadine twice daily
Intervention Type
Drug
Intervention Name(s)
amantadine
Intervention Description
amantadine 100 mg twice daily
Primary Outcome Measure Information:
Title
The primary outcome measure is the Interval Bisection Timing Task.
Time Frame
12 -16 months
Secondary Outcome Measure Information:
Title
The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11).
Time Frame
12-16 moths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleg V. Tcheremissine, MD
Organizational Affiliation
Carolians HealthCare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHS-Behavioral Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.carolinashealthcare.org
Description
Click here for more information about this study and CHS
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Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)
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