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

NCT ID: NCT00227461

Last Updated: 2021-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Aphasia Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Wait control

Levitiracetam is started after a delay, with dosage and administration as described below.

Group Type OTHER

Levetiracetam first, then wait

Intervention Type DRUG

subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design

Treatment first

Levitiracetam is started immediately after baseline data is collected; dosage and administration as described below.

Group Type EXPERIMENTAL

Wait first, then levetiracetam

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Levetiracetam first, then wait

subjects with aphasia will take levetiracetam and we will evaluate their speech, language, and memory in an ABAB design

Intervention Type DRUG

Other Intervention Names

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Keppra Keppra

Eligibility Criteria

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Inclusion Criteria

* Stroke
* Aphasia
* Can give consent

Exclusion Criteria

* Renal failure
* Pregnancy
* Other neurological condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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A. M. Barrett, MD

Director, Stroke Rehabilitation Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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A.M. Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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Kessler Foundation

West Orange, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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none applicable

Identifier Type: -

Identifier Source: secondary_id

AMBarrett1

Identifier Type: -

Identifier Source: org_study_id

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