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Amantadine for Treatment of Symptoms of the Post-traumatic Confusional State

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ClinicalTrials.gov Identifier: NCT00693121
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
Methodist Rehabilitation Center

Tracking Information
First Submitted Date  ICMJE June 4, 2008
First Posted Date  ICMJE June 6, 2008
Last Update Posted Date August 13, 2019
Study Start Date  ICMJE April 2003
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
Confusion Assessment Protocol (number of symptoms) [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00693121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
  • number of participants withdrawn from study due to fulfillment of "escape criteria" [ Time Frame: 14 days ]
  • Time to reach "non-confused" Confusion Assessment Protocol score [ Time Frame: <14 days ]
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 for Treatment of Symptoms of the Post-traumatic Confusional State
Official Title  ICMJE Amantadine Hydrochloride for Treatment of Symptoms of the Post-traumatic Confusional State Among Neurorehabilitation Admissions With TBI: A Randomized, Double-Blind, Placebo-Controlled Trial
Brief Summary

Patients with traumatic brain injury often experience a period of acute confusion that may include agitation as they recover from their injuries. While this confusion generally resolves with time, patients may pose increased risk of injury to themselves or others during this period. Their behavior may also increase stress for family members and interfere with their ability to benefit from rehabilitation therapies. A number of different medications have been used to treat confusion to decrease agitation, decrease risk of injury, and improve participation in rehabilitation therapies. To this point, there has not been a research or scientific basis for knowing which medication is the best for a specific patient. The overall goal of this study is to conduct a scientific investigation to help determine which medication works best to treat confusion.

Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute confusion after traumatic brain injury.

Detailed Description

Patients with TBI who require inpatient rehabilitation are frequently confused at the time of admission for rehabilitation. Our investigations of confusion conducted as part of the TBIMSM have clarified the nature of confusion in early recovery after TBI. Early confusion (PTCS) has been found to be a complex syndrome characterized by disorientation, cognitive impairment, restlessness, decreased level of daytime arousal, sleep disturbance, fluctuation of symptoms, and psychotic-type symptoms. PTCS complicates early management of patients with TBI, and may contribute to increased risk of injury to patients and hospital staff, increased stress among family members and staff, decreased participation in therapies, increased cost of care, and an increased likelihood of being discharged to psychiatric or long-term care settings. These facts indicate the need for effective management of PTCS. Consensus regarding optimal treatment of the cognitive and behavioral symptoms encountered among patients with PTCS does not exist currently. While many agents have been tried to address such symptoms in TBI, few have been investigated systematically. These circumstances indicate the need for appropriate clinical trials to provide guidance to clinicians for medical treatment of PTCS. In response, the NIDRR-Traumatic Brain Injury Model System of Mississippi proposed a randomized, double-blinded, placebo-controlled, parallel group trial for the pharmacological treatment of PTCS. The agent selected for this clinical trial is amantadine, an NMDA and indirect dopamine agonist. This agent will be compared to placebo on response measures of efficacy and safety.

Study hypothesis: Amantadine will reduce the severity and number of symptoms of PTCS.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Posttraumatic Confusional State
  • Delirium
Intervention  ICMJE
  • Drug: Amantadine hydrochloride
    100mg administered orally twice daily x 14 days
  • Drug: Placebo capsule
    capsule, identical to amantadine hydrochloride capsule, administered twice daily x 14 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Identical capsule to amantadine hydrochloride active intervention, administered twice daily x 14 days
    Intervention: Drug: Placebo capsule
  • Active Comparator: Amantadine
    Amantadine hydrochloride 100mg capsule administered twice daily x 14 days
    Intervention: Drug: Amantadine hydrochloride
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2008)
79
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acute Traumatic Brain Injury (≤90 days postinjury)
  • Responsive (not fulfilling criteria for Minimally Conscious State)
  • Meet PTCS criteria on 2 consecutive examinations (as determined by the Confusion Assessment Protocol)
  • Initial neurorehabilitation hospital admission
  • Anticipated ≥2 week length-of-stay after meeting PTCS criteria

Exclusion Criteria:

  • Preexisting seizure disorder
  • Prior history of hospitalization for psychiatric condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older 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 NCT00693121
Other Study ID Numbers  ICMJE MethodistRC Project 1
NIDRR grant #: H133A020514
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theresa San Augustin, National Institute for Disability and Rehabilitation Research
Study Sponsor  ICMJE Methodist Rehabilitation Center
Collaborators  ICMJE U.S. Department of Education
Investigators  ICMJE
Principal Investigator: Stuart A Yablon, M.D. Brain Injury Program, Methodist Rehabilitation Center
Study Director: Mark Sherer, Ph.D. Department of Research, Memorial Hermann/TIRR, Houston, TX
Study Director: Risa N Richardson, Ph.D. Polytrauma Program, James A. Haley Veterans Hospital, Tampa, FL
PRS Account Methodist Rehabilitation Center
Verification Date June 2008

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