Trial Outcomes & Findings for Augmenting Language Therapy for Aphasia: Levodopa (NCT NCT01429077)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

36 participants

Primary outcome timeframe

Change from Baseline in Western Aphasia Battery LQ at 6 weeks

Results posted on

2013-12-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	19	17
Overall Study Completed 6-week Intervention	19	17
Overall Study COMPLETED	19	14
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Lost to Follow-up	0	3

Baseline Characteristics

Augmenting Language Therapy for Aphasia: Levodopa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levodopa n=19 Participants	Inactive Pill n=17 Participants	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	55.1 years STANDARD_DEVIATION 11.8 • n=5 Participants	52.6 years STANDARD_DEVIATION 11.9 • n=7 Participants	54.02 years STANDARD_DEVIATION 11.74 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline in Western Aphasia Battery LQ at 6 weeks

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.

Outcome measures

Outcome measures
Measure	Levodopa/Carbidopa n=19 Participants	Inactive Pill n=14 Participants
Language Quotient (LQ) on the Western Aphasia Battery	3.16 units on a scale Standard Deviation 3.63	2.59 units on a scale Standard Deviation 3.41

SECONDARY outcome

Timeframe: Change from Baseline in functional communication skills at 6 weeks

Scores derived from language sample analyses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from Baseline in participation in everyday activities at 6 weeks

Measures on CETI, QCL,BOSS, CCRSA.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in functional communication skills from 6 weeks to 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change in participation in everyday activities from 6 weeks to 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

Levodopa

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inactive Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leora R. Cherney, PhD

Rehabilitation Institute of Chicago

Phone: 312-238-1117

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place