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

This study has been terminated.
(Principal investigator took a position at another institution. No subjects enrolled.)
Sponsor:
Information provided by:
Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00800514
First received: December 1, 2008
Last updated: July 18, 2011
Last verified: July 2011

December 1, 2008
July 18, 2011
January 2009
November 2010   (final data collection date for primary outcome measure)
The primary outcome measure is the Interval Bisection Timing Task. [ Time Frame: 12 -16 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00800514 on ClinicalTrials.gov Archive Site
The secondary efficacy measure is the Barrett Impulsiveness Scale (BIS-11). [ Time Frame: 12-16 moths ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)
Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury

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.

Not Provided
Interventional
Not Provided
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Traumatic Brain Injury
  • Drug: amantadine
    amantadine twice daily
  • Drug: amantadine
    amantadine 100 mg twice daily
Experimental: active
Interventions:
  • Drug: amantadine
  • Drug: amantadine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00800514
08-01
Yes
Oleg V. Tcheremissine, MD, Carolinas HealthCare System
Carolinas Healthcare System
Not Provided
Principal Investigator: Oleg V. Tcheremissine, MD Carolians HealthCare System
Carolinas Healthcare System
July 2011

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