CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Modafinil +5 moredrug
Likely dose
Modafinil 200 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/NCT01085903
NCT01085903Phase 2Completed
CompareCT.gov

Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

University of Arkansas·interventional·Posted Mar 12, 2010·Updated Oct 18, 2016

In Brief

A Phase 2 clinical trial evaluating Modafinil, Placebo, and 4 other interventions for Spatial Neglect and Dysphagia. Completed, enrolled 28 participants across 2 sites.

Detailed Summary

The purpose of this study is to examine how stroke can alter arousal, alertness, neglect and dysphagia, and whether a medication, modafinil, can improve arousal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpatial Neglect, Dysphagia
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2010
Enrollment StartMar 1, 2010
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 16.3 years ago

Interventions

Modafinildrug

200 mg once daily with morning meal for three days administered only to stroke patients

Placebodrug

Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients

Baselinebehavioral

Observations made at baseline before any intervention

CPSbehavioral

Submerging each participant's foot into ice water (36-44 F) for 50 seconds.

Post CPSbehavioral

20 minutes following the CPS condition.

Follow upbehavioral

Follow up testing occurred at 3 months