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
  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

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

Resource links provided by NLM:


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
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

Responsible Party: Oleg V. Tcheremissine, MD, Carolinas HealthCare System
ClinicalTrials.gov Identifier: NCT00800514     History of Changes
Other Study ID Numbers: 08-01
Study First Received: December 1, 2008
Last Updated: July 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Carolinas Healthcare System:
perception of time, traumatic brain injury, amantadine

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014