CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 79 enrolled
Drug / intervention
Amantadine hydrochloride +1 moredrug
Likely dose
Amantadine hydrochloride 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00693121
NCT00693121Phase 4Completed

Amantadine Hydrochloride for Treatment of Symptoms of the Post-traumatic Confusional State Among Neurorehabilitation Admissions With TBI: A Randomized, Double-Blind, Placebo-Controlled Trial

Methodist Rehabilitation Center·interventional·Posted Jun 6, 2008·Updated Oct 18, 2023

In Brief

A Phase 4 clinical trial evaluating Amantadine hydrochloride and Placebo capsule for Traumatic Brain Injury and 2 related conditions. Completed, enrolled 79 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2008
Enrollment StartApr 1, 2003
Primary CompletionNov 1, 2007
Study CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 18.1 years ago

Interventions

Amantadine hydrochloridedrug

100mg administered orally twice daily x 14 days

Placebo capsuledrug

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