Augmenting Language Therapy for Aphasia: Levodopa

NCT01429077 | Completed Phase 2 Results

• 1 other identifier: H133G070074
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of the medication levodopa, in combination with speech-language treatment, on the language outcome of study subjects with nonfluent aphasia (i.e. difficulty with the comprehension and expression of spoken and written language) following a stroke.

Conditions

Nonfluent Aphasia; Stroke

Keywords

Levodopa; Ischemic Stroke; Aphasia; Speech Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Language Quotient (LQ) on the Western Aphasia Battery

  Includes a measure of auditory comprehension, oral expression, reading and written expression skills. The scale ranges from 1 - 100 with 100 being better. The change or gain score from baseline to immediately post-treatment (at 6 weeks) is reported. The larger the change score, the greater the improvement.

  Change from Baseline in Western Aphasia Battery LQ at 6 weeks

Secondary Outcomes (7)

• Functional Communication Skills

  Change from Baseline in functional communication skills at 6 weeks

• Participation in Everyday Activities

  Change from Baseline in participation in everyday activities at 6 weeks

• Western Aphasia Battery - Reading and Writing Scores

  Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks

• Western Aphasia Battery Aphasia Quotient (Maintenance)

  Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks

• Western Aphasia Battery Reading and Writing Scores (Maintenance)

  Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks

Study Arms (2)

Levodopa/carbidopa

ACTIVE COMPARATOR

The study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.

Drug: levodopa/carbidopa

Inactive pill

PLACEBO COMPARATOR

The placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.

Drug: Placebo comparator

Interventions

levodopa/carbidopa DRUG

The study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.

Also known as: Sinemet

Levodopa/carbidopa

Placebo comparator DRUG

The placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.

Inactive pill

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A single unilateral left-hemisphere stroke
• Nonfluent aphasia, with a mean length of utterance of 0-4 words and an Aphasia Quotient between 20 and 75 on the Western Aphasia Battery
• Age 21 or older.
• At least 6 months post-stroke
• Able to comply with the study protocol
• Premorbidly right-handed, as determined by the Edinburgh Handedness Inventory
• Fluent in English premorbidly
• Completed at least 8th grade education

You may not qualify if:

• More than one stroke
• Any other neurological condition that could potentially affect cognition or speech.
• Global aphasia or inability to participate in routine speech therapy.
• Major active psychiatric illness that may interfere with required study procedures.
• Untreated or inadequately treated depression.
• Has started taking a potentially confounding central nervous system (CNS) drug within the previous 2 months.
• Current abuse of alcohol or drugs
• Nursing a child or pregnant
• Participation in another drug, device or biologics trial within the preceding 90 days
• Unable to understand, cooperate or comply with study procedures
• Significant visual or auditory impairment
• History of sensitivity to ergot derivatives.
• Active medical illness or current medication that precludes safe participation in this study.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Center for Aphasia Research & Treatment

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Aphasia, Broca; Stroke; Ischemic Stroke; Aphasia

Interventions

carbidopa, levodopa drug combination

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

Limitations and Caveats

* Dosage and timing of the L-dopa in relation to the behavioral treatment may not have been optimum. * Efficacy of the behavioral treatment in both arms may have overridden the enhancing effect of the l-dopa in one arm

Results Point of Contact

• Title: Leora R. Cherney, PhD
• Organization: Rehabilitation Institute of Chicago

Lcherney@ric.org

312-238-1117

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: September 5, 2011
• Study Start: October 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 25, 2013
• Results First Posted: November 28, 2013

Record last verified: 2013-11

Locations

US (1)