Trial Outcomes & Findings for Post-stroke Neural Plasticity With Atomoxetine (NCT NCT02788357)
NCT ID: NCT02788357
Last Updated: 2017-08-14
Results Overview
Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.
COMPLETED
PHASE2
12 participants
baseline, post-intervention, 1-month follow-up
2017-08-14
Participant Flow
Participant milestones
| Measure |
Atomoxetine With Motor Training
40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
Placebo With Motor Training
Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Atomoxetine With Motor Training
40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
Placebo With Motor Training
Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Post-stroke Neural Plasticity With Atomoxetine
Baseline characteristics by cohort
| Measure |
Atomoxetine With Motor Training
n=6 Participants
40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
Placebo With Motor Training
n=6 Participants
Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
55.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, post-intervention, 1-month follow-upPopulation: 3 subjects in Atomoxetine group were lost to follow-up.
Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.
Outcome measures
| Measure |
Atomoxetine With Motor Training
n=6 Participants
40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
Placebo With Motor Training
n=6 Participants
Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
|---|---|---|
|
Change in Fugl Meyer Assessment
Post-intervention minus baseline
|
9.3 units on a scale
Interval 5.4 to 13.2
|
2.2 units on a scale
Interval -1.7 to 6.1
|
|
Change in Fugl Meyer Assessment
1-month follow-up minus baseline
|
11.9 units on a scale
Interval 5.9 to 17.9
|
5.8 units on a scale
Interval 1.5 to 10.2
|
SECONDARY outcome
Timeframe: baseline, post-intervention, 1-month follow-upPopulation: 3 subjects in the Atomoxetine group were lost to follow-up.
Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance.
Outcome measures
| Measure |
Atomoxetine With Motor Training
n=6 Participants
40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
Placebo With Motor Training
n=6 Participants
Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
|---|---|---|
|
Change in Action Arm Research Test (ARAT)
Post-intervention minus baseline
|
7.7 units on a scale
Interval 4.6 to 10.7
|
5.3 units on a scale
Interval 2.3 to 8.4
|
|
Change in Action Arm Research Test (ARAT)
1-month follow-up minus baseline
|
10.1 units on a scale
Interval 5.1 to 15.1
|
6.5 units on a scale
Interval 2.6 to 10.4
|
SECONDARY outcome
Timeframe: baseline, post-intervention, 1-month follow-upPopulation: 3 subjects in the Atomoxetine group were lost to follow-up.
Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.
Outcome measures
| Measure |
Atomoxetine With Motor Training
n=6 Participants
40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Atomoxetine: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
Placebo With Motor Training
n=6 Participants
Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Placebo: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
|
|---|---|---|
|
Change in Wolf Motor Function Test (WMFT)
Post-intervention minus baseline
|
-0.1 log(seconds)
Interval -0.26 to 0.06
|
-0.19 log(seconds)
Interval -0.35 to -0.03
|
|
Change in Wolf Motor Function Test (WMFT)
1-month follow-up minus baseline
|
-0.11 log(seconds)
Interval -0.28 to 0.06
|
-0.2 log(seconds)
Interval -0.37 to -0.04
|
SECONDARY outcome
Timeframe: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baselinePopulation: This data is not available at this time, as a relocation occurred during the project. Data collected at the previous institution used different software and stored the data in a different format than is currently used. Therefore, reconciliation of this data is being attempted at this time.
Outcome measures
Outcome data not reported
Adverse Events
Atomoxetine With Motor Training
Placebo With Motor Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place