Keppra to Improve Chronic Aphasia

This study is currently recruiting participants.

Verified by Kessler Medical Rehabilitation Research Center, October 2008

Sponsors and Collaborators:	Kessler Medical Rehabilitation Research Center Kessler Foundation UCB
Information provided by:	Kessler Medical Rehabilitation Research Center
ClinicalTrials.gov Identifier:	NCT00227461

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 I

MedlinePlus related topics: Aphasia Memory

Drug Information available for: Levetiracetam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Official Title:	Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-Stroke Patients.

Further study details as provided by Kessler Medical Rehabilitation Research Center:

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 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental patients are randomized to BABA or ABAB design of receiving drug vs. off-drug period	Drug: Levetiracetam patients are randomized to BABA or ABAB design of receiving drug vs. off-drug period

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

Contacts

Contact: Siby Varughese, RN	973 324-3564	svarughese@kmrrec.org
Contact: Anna Barrett, MD	973 324-3569	abarrett@kmrrec.org

Locations

United States, New Jersey
KMRREC	Recruiting
West Orange, New Jersey, United States, 07052
Contact: Jenny Masmela, BA 973-324-3564 jmasmela@kmrrec.org
Contact: Milda Woods 973 243-6978 mwoods@kmrrec.org

Sponsors and Collaborators

Kessler Medical Rehabilitation Research Center

Kessler Foundation

UCB

Investigators

Principal Investigator:

Anna Barrett, MD

KMRREC

More Information

Responsible Party:	KMRREC ( A. Barrett, Principal Investigator )
Study ID Numbers:	AMBarrett1, none applicable
Study First Received:	September 26, 2005
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00227461
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kessler Medical Rehabilitation Research Center:

Aphasia
Stroke

Study placed in the following topic categories:

Speech Disorders
Cerebral Infarction
Aphasia
Stroke
Vascular Diseases
Central Nervous System Diseases
Language Disorders
Brain Diseases
Cerebrovascular Disorders
Memory Disorders
Cognition Disorders

Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Etiracetam
Dementia
Neurobehavioral Manifestations
Amnesia
Communication Disorders
Delirium

Additional relevant MeSH terms:

Nootropic Agents
Therapeutic Uses
Nervous System Diseases
Cardiovascular Diseases

Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009