CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Armodafinil +1 moredrug
Likely dose
Placebo 150 mgfrom 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/NCT01896128
NCT01896128Phase 2Completed

Use of a Wakefulness-Promoting Agent (Armodafinil) Combined With Neuro-rehabilitation to Improve Neurological Recovery and to Reduce the Incidence of Disability in Patients Who Suffered a Stroke

Burke Rehabilitation Hospital·interventional·Posted Jul 11, 2013·Updated Nov 4, 2019

In Brief

A Phase 2 clinical trial evaluating Armodafinil and Placebo for Stroke and 2 related conditions. Completed, enrolled 19 participants across 1 site.

Detailed Summary

Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a relatively safe agent with interesting neurochemical effects on the catecholamine system, producing an improvement in cognitive function, particularly working memory in humans. When combined with intensive task-related training, armodafinil may accelerate motor recovery in chronic stroke patients. The primary aim of this study is to determine whether administration of armodafinil during subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by armodafinil and, therefore, will induce an improvement in motor function and better performances on measures of motor control.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2013
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 13.0 years ago

Interventions

Armodafinildrug

Placebodrug

inactive pill manufactured to mimic Armodafinil 150 mg tablet