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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Methodist Rehabilitation Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by:
Methodist Rehabilitation Center
ClinicalTrials.gov Identifier:
NCT00693121
First received: June 4, 2008
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Posttraumatic Confusional State
Delirium
Drug: Amantadine hydrochloride
Drug: Placebo capsule
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amantadine Hydrochloride for Treatment of Symptoms of the Post-Traumatic Confusional State Among Neurorehabilitation Admissions With TBI: A Randomized, Double-Blind, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by Methodist Rehabilitation Center:

Primary Outcome Measures:
  • Confusion Assessment Protocol (number of symptoms) [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of participants withdrawn from study due to fulfillment of "escape criteria" [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Time to reach "non-confused" Confusion Assessment Protocol score [ Time Frame: <14 days ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: April 2003
Estimated Study Completion Date: June 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Identical capsule to amantadine hydrochloride active intervention, administered twice daily x 14 days
Drug: Placebo capsule
capsule, identical to amantadine hydrochloride capsule, administered twice daily x 14 days
Active Comparator: Amantadine
Amantadine hydrochloride 100mg capsule administered twice daily x 14 days
Drug: Amantadine hydrochloride
100mg administered orally twice daily x 14 days

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00693121

Locations
United States, Mississippi
Methodist Rehabilitation Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
Methodist Rehabilitation Center
U.S. Department of Education
Investigators
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
  More Information

Publications:
Responsible Party: Theresa San Augustin, National Institute for Disability and Rehabilitation Research
ClinicalTrials.gov Identifier: NCT00693121     History of Changes
Other Study ID Numbers: MethodistRC Project 1, NIDRR grant #: H133A020514
Study First Received: June 4, 2008
Last Updated: June 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Methodist Rehabilitation Center:
Traumatic Brain Injury
Posttraumatic Confusional State
Delirium
Amantadine
Clinical trial

Additional relevant MeSH terms:
Confusion
Delirium
Brain Injuries
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
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 14, 2014