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Augmenting Language Therapy for Aphasia: Levodopa

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Leora Cherney, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01429077
First received: August 2, 2011
Last updated: November 27, 2013
Last verified: November 2013
Results First Received: June 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Nonfluent Aphasia
Stroke
Interventions: Drug: levodopa/carbidopa
Drug: Placebo comparator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Levodopa 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.
Inactive Pill The inactive pill was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.

Participant Flow:   Overall Study
    Levodopa     Inactive Pill  
STARTED     19     17  
Completed 6-week Intervention     19     17  
COMPLETED     19     14  
NOT COMPLETED     0     3  
Lost to Follow-up                 0                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Levodopa No text entered.
Inactive Pill No text entered.
Total Total of all reporting groups

Baseline Measures
    Levodopa     Inactive Pill     Total  
Number of Participants  
[units: participants]
  19     17     36  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     15     29  
>=65 years     5     2     7  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 11.8     52.6  ± 11.9     54.02  ± 11.74  
Gender  
[units: participants]
     
Female     10     6     16  
Male     9     11     20  
Region of Enrollment  
[units: participants]
     
United States     19     17     36  



  Outcome Measures

1.  Primary:   Language Quotient (LQ) on the Western Aphasia Battery   [ Time Frame: Change from Baseline in Western Aphasia Battery LQ at 6 weeks ]

2.  Secondary:   Functional Communication Skills   [ Time Frame: Change from Baseline in functional communication skills at 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Participation in Everyday Activities   [ Time Frame: Change from Baseline in participation in everyday activities at 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Western Aphasia Battery - Reading and Writing Scores   [ Time Frame: Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Western Aphasia Battery Aphasia Quotient (Maintenance)   [ Time Frame: Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Western Aphasia Battery Reading and Writing Scores (Maintenance)   [ Time Frame: Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Functional Communication Skills (Maintenance)   [ Time Frame: Change in functional communication skills from 6 weeks to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Participation in Everyday Activities (Maintenance)   [ Time Frame: Change in participation in everyday activities from 6 weeks to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
  • 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


  More Information
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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
e-mail: Lcherney@ric.org


No publications provided


Responsible Party: Leora Cherney, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier: NCT01429077     History of Changes
Other Study ID Numbers: H133G070074
Study First Received: August 2, 2011
Results First Received: June 5, 2013
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board