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

NCT00227461 | Unknown Phase 1 DMC

• 2 other identifiers: AMBarrett1none applicable
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aphasia; Stroke

Keywords

Aphasia; Stroke

Outcome Measures

Primary Outcomes (1)

• Speech and language assessment

  6 months - 1year

Secondary Outcomes (1)

• Memory assessment

  6 months to 1 year

Study Arms (2)

Wait control

OTHER

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

Drug: Levetiracetam first, then wait

Treatment first

EXPERIMENTAL

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

Drug: Wait first, then levetiracetam

Interventions

Wait first, then levetiracetam 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.

Also known as: Keppra

Treatment first

Levetiracetam first, then wait DRUG

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

Also known as: Keppra

Wait control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke
• Aphasia
• Can give consent

You may not qualify if:

• Renal failure
• Pregnancy
• Other neurological condition

Sponsors & Collaborators

• Kessler Foundation: lead
• UCB Pharma: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Aphasia; Stroke

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• A.M. Barrett, MD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Stroke Rehabilitation Research

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

US (1)