Official Title: “Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-Stroke Patients.”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam
  • patients are randomized to BABA or ABAB design of receiving drug vs. off-drug period

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • patients are randomized to BABA or ABAB design of receiving drug vs. off-drug period

Primary Measures

• Speech and language assessment
  • Time Frame: 6 months - 1year
    Safety Issue?: No

Secondary Measures

• Memory assessment
  • Time Frame: 6 months to 1 year
    Safety Issue?: No

Inclusion Criteria:

• Stroke
• Aphasia
• Can give consent

Exclusion Criteria:

• Renal failure
• Pregnancy
• Other neurological condition

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kessler Medical Rehabilitation Research Center

Overall Clinical Trial Officials and Contacts

Anna Barrett, MD Principal Investigator KMRREC  

Overall Contact: Siby Varughese, RN 973 324-3564 svarughese@kmrrec.org

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00227461

Study ID Number: AMBarrett1

ClinicalTrials.gov Identifier: NCT00227461

Health Authority: United States: Food and Drug Administration