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

NCT00693121 | Completed Phase 4

• 2 other identifiers: MethodistRC Project 1NIDRR grant #: H133A020514
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Posttraumatic Confusional State; Delirium

Keywords

Traumatic Brain Injury; Posttraumatic Confusional State; Delirium; Amantadine; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Confusion Assessment Protocol (number of symptoms)

  14 days

Secondary Outcomes (2)

• number of participants withdrawn from study due to fulfillment of "escape criteria"

  14 days

• Time to reach "non-confused" Confusion Assessment Protocol score

  <14 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Identical capsule to amantadine hydrochloride active intervention, administered twice daily x 14 days

Drug: Placebo capsule

Amantadine

ACTIVE COMPARATOR

Amantadine hydrochloride 100mg capsule administered twice daily x 14 days

Drug: Amantadine hydrochloride

Interventions

Amantadine hydrochloride DRUG

100mg administered orally twice daily x 14 days

Amantadine

Placebo capsule DRUG

capsule, identical to amantadine hydrochloride capsule, administered twice daily x 14 days

Placebo

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Preexisting seizure disorder
• Prior history of hospitalization for psychiatric condition

Sponsors & Collaborators

• Methodist Rehabilitation Center: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Methodist Rehabilitation Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (4)

• Sherer M, Yablon SA, Nakase-Richardson R, Nick TG. Effect of severity of post-traumatic confusion and its constituent symptoms on outcome after traumatic brain injury. Arch Phys Med Rehabil. 2008 Jan;89(1):42-7. doi: 10.1016/j.apmr.2007.08.128.

  PMID: 18164329 BACKGROUND

• Nakase-Richardson R, Yablon SA, Sherer M. Prospective comparison of acute confusion severity with duration of post-traumatic amnesia in predicting employment outcome after traumatic brain injury. J Neurol Neurosurg Psychiatry. 2007 Aug;78(8):872-6. doi: 10.1136/jnnp.2006.104190. Epub 2006 Dec 18.

  PMID: 17178822 BACKGROUND

• Sherer M, Nakase-Thompson R, Yablon SA, Gontkovsky ST. Multidimensional assessment of acute confusion after traumatic brain injury. Arch Phys Med Rehabil. 2005 May;86(5):896-904. doi: 10.1016/j.apmr.2004.09.029.

  PMID: 15895334 BACKGROUND

• Nakase-Thompson R, Sherer M, Yablon SA, Nick TG, Trzepacz PT. Acute confusion following traumatic brain injury. Brain Inj. 2004 Feb;18(2):131-42. doi: 10.1080/0269905031000149542.

  PMID: 14660226 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Delirium

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Stuart A Yablon, M.D.

  Brain Injury Program, Methodist Rehabilitation Center

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: April 1, 2003
• Primary Completion: November 1, 2007
• Study Completion: March 1, 2019
• Last Updated: October 18, 2023

Record last verified: 2008-06

Locations

US (1)