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

February 16, 2021 updated by: A. M. Barrett, MD, Kessler Foundation
The study investigates the possibility that levetiracetam may improve the symptoms of chronic post-stroke aphasia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke
  • Aphasia
  • Can give consent

Exclusion Criteria:

  • Renal failure
  • Pregnancy
  • Other neurological condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Wait control
Levitiracetam is started after a delay, with dosage and administration as described below.
Drug: Levetiracetam first, then wait
subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design
Other Names:
  • Keppra
Experimental: Treatment first
Levitiracetam is started immediately after baseline data is collected; dosage and administration as described below.
Drug: Wait first, then 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 Names:
  • Keppra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Speech and language assessment
Time Frame: 6 months - 1year
6 months - 1year

Secondary Outcome Measures

Outcome Measure
Time Frame
Memory assessment
Time Frame: 6 months to 1 year
6 months to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

UCB Pharma

Investigators

  • Principal Investigator: A.M. Barrett, MD, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2005

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 26, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMBarrett1
  • none applicable

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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