This Study is to Learn Whether Keppra May Improve Aphasia, Memory, Naming, and Speech Initiation After Stroke

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

Brief Summary

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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: June 2012

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: Levetiracetam
    • 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 there are no significant problems with this dose, it will then be increased to 750 mg orally twice daily for another 7 days and then finally increased to 1000 mg orally twice daily for 7 days.

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Kessler Foundation Other

Overall Clinical Trial Officials and Contacts

Anna Barrett, MD Principal Investigator Kessler Foundation  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00227461