drugset / Trial / NCT00219245

An Extension Study Evaluating the Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury (TBI) With Persistent Cognitive Deficits

NCT00219245

Phase 4 Completed 157 enrolled Novartis
RandomizedSingle-groupOpen-label

Summary

Patients who completed the 12-week double blind protocol may enter this 26-week, open-label extension. This extension will give patients who complete the study an opportunity to receive treatment with open-label rivastigmine 3-12 mg/day and further evaluation for the cognitive deficits related to traumatic brain injury. This extension will enable further evaluation of patients, as well as analyses to be conducted examining response to treatments in the original drug and placebo groups.

Timeline

Start
2002-11
Primary completion
2005-01
Completion
2005-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivastigmine Small molecule 3 mg
Subject Rivastigmine Small molecule 12 mg