Trial Outcomes & Findings for Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke (NCT NCT01896128)
NCT ID: NCT01896128
Last Updated: 2019-11-04
Results Overview
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke.The maximum possible score in Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. The five domains assessed by Fugl-Meyer scale are: * Motor function (Maximum score in upper limb = 66;Maximum score in lower limb = 34) * Sensory function (Maximum score = 24) * Balance (Maximum score = 14) * Range of motion of joints (Maximum score = 44) * Joint pain (Maximum score = 44)
COMPLETED
PHASE2
19 participants
Baseline to Day 100
2019-11-04
Participant Flow
Participant milestones
| Measure |
Armodafinil
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Armodafinil
|
Placebo
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Armodafinil
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Armodafinil
|
Placebo
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
Baseline characteristics by cohort
| Measure |
Armodafinil
n=8 Participants
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Armodafinil
|
Placebo
n=11 Participants
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 12.4 • n=99 Participants
|
67.5 years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
66.45 years
STANDARD_DEVIATION 10.95 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
11 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 100Population: data available for participants who completed the study
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke.The maximum possible score in Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. The five domains assessed by Fugl-Meyer scale are: * Motor function (Maximum score in upper limb = 66;Maximum score in lower limb = 34) * Sensory function (Maximum score = 24) * Balance (Maximum score = 14) * Range of motion of joints (Maximum score = 44) * Joint pain (Maximum score = 44)
Outcome measures
| Measure |
Armodafinil
n=5 Participants
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Armodafinil
|
Placebo
n=8 Participants
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet
|
|---|---|---|
|
Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100
Baseline
|
14.8 units on a scale
Standard Deviation 8.6
|
12.8 units on a scale
Standard Deviation 7.0
|
|
Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100
Day100
|
39.7 units on a scale
Standard Deviation 15.0
|
37.8 units on a scale
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: Day 100The FIM is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires. The motor subscale includes:Eating,Grooming,BathingDressing, upper body,Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchairTransfers - toiletTransfers - bath/showerWalk/wheelchairStairs The cognition subscale includes:Comprehension ExpressionSocial interaction Problem solvingMemory Each item is scored on a 7 point ordinal scale, ranging from a score of 1(worse) to a score of 7(better). The total score for the FIM motor subscale (the sum of motor subscale ) will be a value between 13 and 91.The total score for the FIM cognition subscale (the sum of the individual cognition subscale items) will be a value between 5(worse outcome) \& 35(best outcome).The total score for the FIM instrument (the sum of subscale scores) will be a value between 18(worse outcome) \& 126 (best outcome)
Outcome measures
| Measure |
Armodafinil
n=8 Participants
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Armodafinil
|
Placebo
n=11 Participants
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet
|
|---|---|---|
|
Change in Functional Independence Measure (FIM) From Baseline to Day 100
Day100
|
89.2 units on a scale
Standard Deviation 21.7
|
90.9 units on a scale
Standard Deviation 17.4
|
|
Change in Functional Independence Measure (FIM) From Baseline to Day 100
Baseline
|
55.5 units on a scale
Standard Deviation 17.8
|
52.4 units on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: Day 1, Day 100The 3MWT is a simple measure of the distance a person can walk in three minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed e.g. for elderly people with a record made of walking aid used.A clear course such as a hallway with cones or similar to mark an approximately 15m "out and back" course\[8\], stopwatch, pen and paper or a device to record distance walked.
Outcome measures
| Measure |
Armodafinil
n=8 Participants
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Armodafinil
|
Placebo
n=11 Participants
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet
|
|---|---|---|
|
Timed 3-Minute Walk Test From Baseline to Day 100
Baseline
|
49.4 feet
Standard Deviation 43.5
|
152.5 feet
Standard Deviation 89.2
|
|
Timed 3-Minute Walk Test From Baseline to Day 100
Day100
|
152.5 feet
Standard Deviation 89.2
|
103.3 feet
Standard Deviation 73.8
|
SECONDARY outcome
Timeframe: Baseline Day 100The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 Score. Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Outcome measures
| Measure |
Armodafinil
n=8 Participants
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Armodafinil
|
Placebo
n=11 Participants
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet
|
|---|---|---|
|
NIH Stroke Scale (NIHSS)
Baseline
|
11.9 units on a scale
Standard Error 3.9
|
13.4 units on a scale
Standard Error 3.3
|
|
NIH Stroke Scale (NIHSS)
Day100
|
6.7 units on a scale
Standard Error 2.5
|
7.3 units on a scale
Standard Error 2.7
|
SECONDARY outcome
Timeframe: Baseline & Day 1009 HOLE PEG TEST * Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible * Participants must then remove the pegs from the holes, one by one, and replace them back into the container * The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested * Only the hand being evaluated should perform the test * Hand not being evaluated is permitted to hold the edge of the board in order to provide stability * Scores are based on the time taken to complete the test activity, recorded in seconds * Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second * Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container
Outcome measures
| Measure |
Armodafinil
n=8 Participants
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Armodafinil
|
Placebo
n=11 Participants
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet
|
|---|---|---|
|
9-Hole Peg Test
Baseline
|
34.0 Seconds
Standard Error 8.8
|
34.2 Seconds
Standard Error 9.5
|
|
9-Hole Peg Test
Day100
|
27.3 Seconds
Standard Error 6.7
|
29.7 Seconds
Standard Error 6.1
|
Adverse Events
Armodafinil
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Armodafinil
n=8 participants at risk
150 mg armodafinil administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Armodafinil
|
Placebo
n=11 participants at risk
inactive agent administered 2 hours prior to start of therapeutic regimen for 10 consecutive days
Placebo: inactive pill manufactured to mimic Armodafinil 150 mg tablet
|
|---|---|---|
|
Nervous system disorders
Nervesousness
|
12.5%
1/8 • Number of events 1 • 100 days
|
0.00%
0/11 • 100 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place