This Study is to Learn Whether Keppra May Improve Aphasia, Memory, Naming, and Speech Initiation After Stroke
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
- Time Frame: 6 months - 1year
Secondary Measures
- Memory assessment
- Time Frame: 6 months to 1 year
Safety Issue?: No
- Time Frame: 6 months to 1 year
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
