Overview

This trial is active, not recruiting.

Conditions aphasia, stroke
Treatments levetiracetam
Phase phase 1
Sponsor Kessler Foundation
Collaborator UCB Pharma
Start date September 2005
End date June 2016
Trial size 50 participants
Trial identifier NCT00227461, AMBarrett1, none applicable

Summary

The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Levitiracetam is started after a delay.
levetiracetam Keppra
subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design
(Experimental)
Levitiracetam is started immediately after baseline data is collected.
levetiracetam Keppra
Levetiracetam 250 mg orally twice daily for 7 days. This will increase to 500 mg oral twice daily for 7 days the following week. If this dose is tolerated, it will then be increased to 750 mg orally twice daily for another 7 days and then increased to 1000 mg orally twice daily for 7 days.

Primary Outcomes

Measure
Speech and language assessment
time frame: 6 months - 1year

Secondary Outcomes

Measure
Memory assessment
time frame: 6 months to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Stroke - Aphasia - Can give consent Exclusion Criteria: - Renal failure - Pregnancy - Other neurological condition

Additional Information

Official title Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.
Principal investigator A.M. Barrett, MD
Description In the study, 50 post-stroke subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Kessler Foundation.