Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)
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ClinicalTrials.gov Identifier: NCT00800514 |
Recruitment Status :
Terminated
(Principal investigator took a position at another institution. No subjects enrolled.)
First Posted : December 2, 2008
Last Update Posted : July 19, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Traumatic Brain Injury | Drug: amantadine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: active |
Drug: amantadine
amantadine twice daily Drug: amantadine amantadine 100 mg twice daily |
- The primary outcome measure is the Interval Bisection Timing Task. [ Time Frame: 12 -16 months ]
- The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). [ Time Frame: 12-16 moths ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800514
United States, North Carolina | |
CHS-Behavioral Health Research | |
Charlotte, North Carolina, United States, 28211 |
Principal Investigator: | Oleg V. Tcheremissine, MD | Carolians HealthCare System |
Responsible Party: | Oleg V. Tcheremissine, MD, Carolinas HealthCare System |
ClinicalTrials.gov Identifier: | NCT00800514 |
Other Study ID Numbers: |
08-01 |
First Posted: | December 2, 2008 Key Record Dates |
Last Update Posted: | July 19, 2011 |
Last Verified: | July 2011 |
perception of time, traumatic brain injury, amantadine |
Brain Injuries Brain Injuries, Traumatic Wounds and Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Amantadine Antiparkinson Agents Anti-Dyskinesia Agents |
Antiviral Agents Anti-Infective Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |