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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

Tracking Information
First Submitted Date  ICMJE December 1, 2008
First Posted Date  ICMJE December 2, 2008
Last Update Posted Date July 19, 2011
Study Start Date  ICMJE January 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
The primary outcome measure is the Interval Bisection Timing Task. [ Time Frame: 12 -16 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00800514 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2008)
The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). [ Time Frame: 12-16 moths ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)
Official Title  ICMJE Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • Drug: amantadine
    amantadine twice daily
  • Drug: amantadine
    amantadine 100 mg twice daily
Study Arms  ICMJE Experimental: active
Interventions:
  • Drug: amantadine
  • Drug: amantadine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: December 1, 2008)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00800514
Other Study ID Numbers  ICMJE 08-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oleg V. Tcheremissine, MD, Carolinas HealthCare System
Study Sponsor  ICMJE Atrium Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Oleg V. Tcheremissine, MD Carolians HealthCare System
PRS Account Atrium Health
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP