Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00227461|
Recruitment Status : Active, not recruiting
First Posted : September 28, 2005
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aphasia Stroke||Drug: Wait first, then levetiracetam Drug: Levetiracetam first, then wait||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.|
|Actual Study Start Date :||September 2005|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Levitiracetam is started after a delay, with dosage and administration as described below.
Drug: Levetiracetam first, then wait
subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design
Other Name: Keppra
Experimental: Treatment first
Levitiracetam is started immediately after baseline data is collected; dosage and administration as described below.
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.
Other Name: Keppra
- Speech and language assessment [ Time Frame: 6 months - 1year ]
- Memory assessment [ Time Frame: 6 months to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227461
|United States, New Jersey|
|West Orange, New Jersey, United States, 07052|
|Principal Investigator:||A.M. Barrett, MD||Kessler Foundation|