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

Primary Purpose

Aphasia, Stroke

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Wait first, then levetiracetam

Levetiracetam first, then wait

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Stroke Aphasia Can give consent Exclusion Criteria: Renal failure Pregnancy Other neurological condition

Sites / Locations

Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Wait control

Treatment first

Arm Description

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

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

Outcomes

Primary Outcome Measures

Speech and language assessment

Secondary Outcome Measures

Memory assessment

Full Information

NCT ID

NCT00227461

First Posted

September 26, 2005

Last Updated

February 16, 2021

Sponsor

Kessler Foundation

Collaborators

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00227461

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 2005 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kessler Foundation

Collaborators

UCB Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphasia, Stroke

Keywords

Aphasia, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Wait control

Arm Type

Other

Arm Description

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

Arm Title

Treatment first

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Wait first, then levetiracetam

Other Intervention Name(s)

Keppra

Intervention Description

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

Intervention Name(s)

Levetiracetam first, then wait

Other Intervention Name(s)

Keppra

Intervention Description

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

Primary Outcome Measure Information:

Title

Speech and language assessment

Time Frame

6 months - 1year

Secondary Outcome Measure Information:

Title

Memory assessment

Time Frame

6 months to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Stroke Aphasia Can give consent Exclusion Criteria: Renal failure Pregnancy Other neurological condition

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

A.M. Barrett, MD

Organizational Affiliation

Kessler Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kessler Foundation

City

West Orange

State/Province

New Jersey

ZIP/Postal Code

07052

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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