Phase 3
Completed N=36
Augmenting Language Therapy for Aphasia: Levodopa
Nonfluent Aphasia · Stroke
Source: ClinicalTrials.gov NCT01429077 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Language Quotient (LQ) on the Western Aphasia Battery — 3.16; 2.59 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Language Quotient (LQ) on the Western Aphasia Battery |
3.16; 2.59 | — |
| SECONDARY Functional Communication Skills |
— | — |
| SECONDARY Participation in Everyday Activities |
— | — |
| SECONDARY Western Aphasia Battery - Reading and Writing Scores |
— | — |
| SECONDARY Western Aphasia Battery Aphasia Quotient (Maintenance) |
— | — |
| SECONDARY Western Aphasia Battery Reading and Writing Scores (Maintenance) |
— | — |
| SECONDARY Functional Communication Skills (Maintenance) |
— | — |
| SECONDARY Participation in Everyday Activities (Maintenance) |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01429077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.