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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
A. M. Barrett, MD, Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00227461
First received: September 26, 2005
Last updated: March 10, 2014
Last verified: March 2014
  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
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 2014
Estimated Primary Completion Date: June 2014 (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

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
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, see Learn About Clinical Studies.

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 Pharma
Investigators
Principal Investigator: A.M. Barrett, MD Kessler Foundation
  More Information

No publications provided

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 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Kessler Foundation:
Aphasia
Stroke

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

ClinicalTrials.gov processed this record on October 16, 2014