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

This study is not yet open for participant recruitment.

Verified by Carolinas Healthcare System, December 2008

Sponsored by:	Carolinas Healthcare System
Information provided by:	Carolinas Healthcare System
ClinicalTrials.gov Identifier:	NCT00800514

Purpose

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	Intervention
Traumatic Brain Injury	Drug: amantadine

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Amantadine Amantadine hydrochloride Amantadine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Single Blind (Subject), Crossover Assignment
Official Title:	Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury

Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:

The primary outcome measure is the Interval Bisection Timing Task. [ Time Frame: 12 -16 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). [ Time Frame: 12-16 moths ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	16
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
active: Experimental	Drug: amantadine amantadine twice daily Drug: amantadine amantadine 100 mg twice daily

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800514

Contacts

Contact: Karyn L Riedal, RN

704-446-7509

kriedal@carolinas.org

Locations

United States, North Carolina
CHS-Behavioral Health Research
Charlotte, North Carolina, United States, 28211

Sponsors and Collaborators

Carolinas Healthcare System

Investigators

Principal Investigator:

Oleg V. Tcheremissine, MD

Carolians HealthCare System

More Information

Click here for more information about this study and CHS This link exits the ClinicalTrials.gov site

Responsible Party:	Carolinas HealthCare System ( Oleg V. Tcheremissine, MD )
Study ID Numbers:	08-01
Study First Received:	December 1, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00800514
Health Authority:	United States: Food and Drug Administration

Keywords provided by Carolinas Healthcare System:

perception of time, traumatic brain injury, amantadine

Study placed in the following topic categories:

Craniocerebral Trauma
Dopamine
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Amantadine
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Anti-Infective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Antiviral Agents

Pharmacologic Actions
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009