CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
levodopa/carbidopa +1 moredrug
Likely dose
levodopa/carbidopa 100 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/NCT01429077
NCT01429077Phase 3Completed

Augmenting Language Therapy for Aphasia: A Randomized Double-Blind Placebo-Controlled Trial of Levodopa in Combination With Speech-Language Therapy

Shirley Ryan AbilityLab·interventional·Posted Sep 5, 2011·Updated Dec 25, 2013

In Brief

A Phase 3 clinical trial evaluating levodopa/carbidopa and Placebo comparator for Nonfluent Aphasia and Stroke. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effectiveness of the medication levodopa, in combination with speech-language treatment, on the language outcome of study subjects with nonfluent aphasia (i.e. difficulty with the comprehension and expression of spoken and written language) following a stroke.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2011
Enrollment StartOct 1, 2007
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.8 years ago

Interventions

levodopa/carbidopadrug

The study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.

Placebo comparatordrug

The placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.