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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by A. M. Barrett, MD, Kessler Foundation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227461
First Posted: September 28, 2005
Last Update Posted: April 1, 2015
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.
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
A. M. Barrett, MD, Kessler Foundation
  Purpose
The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.

Condition Intervention Phase
Aphasia Stroke Drug: Levetiracetam Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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 A. M. Barrett, MD, Kessler Foundation:

Primary Outcome Measures:
  • Speech and language assessment [ Time Frame: 6 months - 1year ]

Secondary Outcome Measures:
  • Memory assessment [ Time Frame: 6 months to 1 year ]

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stroke
  • Aphasia
  • Can give consent

Exclusion Criteria:

  • Renal failure
  • Pregnancy
  • Other neurological condition
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, New Jersey
Kessler Foundation
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
UCB Pharma
Investigators
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
First Submitted: September 26, 2005
First Posted: September 28, 2005
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by A. M. Barrett, MD, Kessler Foundation:
Aphasia
Stroke

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