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

Sponsor
Kessler Foundation (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00227461
Collaborator
UCB Pharma (Industry)
50
Enrollment
1
Location
2
Arms
195
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Wait first, then levetiracetam
  • Drug: Levetiracetam first, then wait
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
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.
Actual Study Start Date :
Sep 1, 2005
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Speech and language assessment [6 months - 1year]

    Secondary Outcome Measures

    1. Memory assessment [6 months to 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Stroke

    • Aphasia

    • Can give consent

    Exclusion Criteria:

    • Renal failure

    • Pregnancy

    • Other neurological condition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    A. M. Barrett, MD, Director, Stroke Rehabilitation Research, Kessler Foundation
    ClinicalTrials.gov Identifier:
    NCT00227461
    Other Study ID Numbers:
    • AMBarrett1
    • none applicable
    First Posted:
    Sep 28, 2005
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by A. M. Barrett, MD, Director, Stroke Rehabilitation Research, Kessler Foundation
    Aphasia
    Stroke
    Additional relevant MeSH terms:
    Stroke
    Aphasia
    Levetiracetam

    Study Results

    No Results Posted as of Feb 17, 2021