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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by:
Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00227461
First received: September 26, 2005
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Aphasia
Stroke
Amnesia
 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:

MedlinePlus related topics: Aphasia Memory
U.S. FDA Resources

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 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    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.

  Eligibility

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

Inclusion Criteria:

  • Stroke
  • Aphasia
  • Can give consent

Exclusion Criteria:

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

Locations
United States, New Jersey
Kessler Foundation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
UCB, Inc.
Investigators
Principal Investigator: Anna Barrett, MD Kessler Foundation
  More Information

No publications provided

Responsible Party: A. Barrett, Principal Investigator, Kessler Foundation
ClinicalTrials.gov Identifier: NCT00227461     History of Changes
Other Study ID Numbers: AMBarrett1, none applicable
Study First Received: September 26, 2005
Last Updated: June 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Kessler Foundation:
Aphasia
Stroke

Additional relevant MeSH terms:
Amnesia
Aphasia
Stroke
Cerebral Infarction
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Speech Disorders
Language Disorders
Communication Disorders
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013