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Augmenting Language Therapy for Aphasia: Levodopa

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ClinicalTrials.gov Identifier: NCT01429077
Recruitment Status : Completed
First Posted : September 5, 2011
Results First Posted : November 28, 2013
Last Update Posted : December 25, 2013
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Leora Cherney, Shirley Ryan AbilityLab

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Nonfluent Aphasia
Stroke
Interventions Drug: levodopa/carbidopa
Drug: Placebo comparator
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levodopa Inactive Pill
Hide Arm/Group Description The study drug (100 mg levodopa / 25 mg carbidopa), was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks. The inactive pill was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
Period Title: Overall Study
Started 19 17
Completed 6-week Intervention 19 17
Completed 19 14
Not Completed 0 3
Reason Not Completed
Lost to Follow-up             0             3
Arm/Group Title Levodopa Inactive Pill Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 19 17 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  73.7%
15
  88.2%
29
  80.6%
>=65 years
5
  26.3%
2
  11.8%
7
  19.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 17 participants 36 participants
55.1  (11.8) 52.6  (11.9) 54.02  (11.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
Female
10
  52.6%
6
  35.3%
16
  44.4%
Male
9
  47.4%
11
  64.7%
20
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 17 participants 36 participants
19 17 36
1.Primary Outcome
Title Language Quotient (LQ) on the Western Aphasia Battery
Hide Description

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.

Time Frame Change from Baseline in Western Aphasia Battery LQ at 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levodopa/Carbidopa Inactive Pill
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.16  (3.63) 2.59  (3.41)
2.Secondary Outcome
Title Functional Communication Skills
Hide Description Scores derived from language sample analyses
Time Frame Change from Baseline in functional communication skills at 6 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Participation in Everyday Activities
Hide Description Measures on CETI, QCL,BOSS, CCRSA.
Time Frame Change from Baseline in participation in everyday activities at 6 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Western Aphasia Battery - Reading and Writing Scores
Hide Description [Not Specified]
Time Frame Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Western Aphasia Battery Aphasia Quotient (Maintenance)
Hide Description [Not Specified]
Time Frame Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Western Aphasia Battery Reading and Writing Scores (Maintenance)
Hide Description [Not Specified]
Time Frame Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Functional Communication Skills (Maintenance)
Hide Description [Not Specified]
Time Frame Change in functional communication skills from 6 weeks to 12 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Participation in Everyday Activities (Maintenance)
Hide Description [Not Specified]
Time Frame Change in participation in everyday activities from 6 weeks to 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levodopa Inactive Pill
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Levodopa Inactive Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levodopa Inactive Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levodopa Inactive Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/14 (0.00%) 
  • 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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Leora R. Cherney, PhD
Organization: Rehabilitation Institute of Chicago
Phone: 312-238-1117
Responsible Party: Leora Cherney, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT01429077     History of Changes
Other Study ID Numbers: H133G070074
First Submitted: August 2, 2011
First Posted: September 5, 2011
Results First Submitted: June 5, 2013
Results First Posted: November 28, 2013
Last Update Posted: December 25, 2013