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NCT00227461 Clinical Trial

Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.

Stroke Clinical Trial

Official title:
Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00227461
Other study ID # AMBarrett1
Secondary ID none applicable
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date September 2005
Est. completion date December 2021

Study information
Verified date February 2021
Source Kessler Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Stroke - Aphasia - Can give consent Exclusion Criteria: - Renal failure - Pregnancy - Other neurological condition

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Wait first, then 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 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.
• Levetiracetam first, then wait
subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design

Locations
Country Name City State
United States Kessler Foundation West Orange New Jersey

Sponsors (2)
Lead Sponsor Collaborator
Kessler Foundation UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Speech and language assessment 6 months - 1year
Secondary Memory assessment 6 months to 1 year
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