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

This study is ongoing, but not recruiting participants.
UCB Pharma
Information provided by (Responsible Party):
A. M. Barrett, MD, Kessler Foundation
ClinicalTrials.gov Identifier:
First received: September 26, 2005
Last updated: March 31, 2015
Last verified: March 2015
The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.

Condition Intervention Phase
Drug: Levetiracetam
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients.

Resource links provided by NLM:

Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • Speech and language assessment [ Time Frame: 6 months - 1year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Memory assessment [ Time Frame: 6 months to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2005
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Wait control
Levitiracetam is started after a delay.
Drug: Levetiracetam
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.
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 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

Detailed 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stroke
  • Aphasia
  • Can give consent

Exclusion Criteria:

  • Renal failure
  • Pregnancy
  • Other neurological condition
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00227461

United States, New Jersey
Kessler Foundation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
UCB Pharma
Principal Investigator: A.M. Barrett, MD Kessler Foundation
  More Information

Responsible Party: A. M. Barrett, MD, Director, Stroke Rehabilitation Research, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00227461     History of Changes
Other Study ID Numbers: AMBarrett1  none applicable 
Study First Received: September 26, 2005
Last Updated: March 31, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Kessler Foundation:

Additional relevant MeSH terms:
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders
Vascular Diseases
Neuroprotective Agents
Nootropic Agents
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2016