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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Atrium Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: amantadine Not Applicable

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: active Drug: amantadine
amantadine twice daily

Drug: amantadine
amantadine 100 mg twice daily


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome measure is the Interval Bisection Timing Task. [ Time Frame: 12 -16 months ]

Secondary Outcome Measures :
  1. The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). [ Time Frame: 12-16 moths ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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United States, North Carolina
CHS-Behavioral Health Research
Charlotte, North Carolina, United States, 28211
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Oleg V. Tcheremissine, MD Carolians HealthCare System
More Information
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Additional Information:
Click here for more information about this study and CHS  This link exits the ClinicalTrials.gov site

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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
Keywords provided by Atrium Health:
perception of time, traumatic brain injury, amantadine
Additional relevant MeSH terms:
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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