Trial Outcomes & Findings for Study of Botulinum Toxin and Recovery of Hand Function After Stroke (NCT NCT01422161)
NCT ID: NCT01422161
Last Updated: 2019-06-20
Results Overview
Assessments are done on day 1, before the 1st Botulinum toxin injection. They will be assessed for: * Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function.
COMPLETED
PHASE3
16 participants
Day 1
2019-06-20
Participant Flow
Sample size is estimated based on a treatment difference of 20% between the two groups
Participant milestones
| Measure |
Botulinum Toxin Commonly Known as BOTOX®
Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.
Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
|
Placebo
Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.
The control group will receive a placebo injection.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Botulinum Toxin and Recovery of Hand Function After Stroke
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Commonly Known as BOTOX®
n=10 Participants
Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.
Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study.
|
Placebo
n=6 Participants
Some subject will receive a safe Placebo injection. Subjects will not be informed of what injection they have received.
Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study.
|
Total
n=16 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
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
6 participants
n=107 Participants
|
16 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Improved motor execution as measured by the time taken to form a stable grasp.
Assessments are done on day 1, before the 1st Botulinum toxin injection. They will be assessed for: * Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function.
Outcome measures
| Measure |
Control (Saline) Group -PRE Treatment
n=6 Participants
Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.
Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study.
|
Botox Group -PRE Treatment
n=10 Participants
A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
There will be 1 treatment cycle during the 9 week study.
|
|---|---|---|
|
Time Taken to Form a Stable Grasp Pre-Treatment
|
1.51 Preload phase duration in Seconds
Standard Error .21
|
1.14 Preload phase duration in Seconds
Standard Error .59
|
PRIMARY outcome
Timeframe: 90 DaysPopulation: Time taken to form a stable grasp.
* Hand motor impairment (execution and planning) during a functional grasp and lift tasks. * Hand function.
Outcome measures
| Measure |
Control (Saline) Group -PRE Treatment
n=6 Participants
Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.
Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study.
|
Botox Group -PRE Treatment
n=10 Participants
A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
There will be 1 treatment cycle during the 9 week study.
|
|---|---|---|
|
Time Taken to Form a Stable Grasp Post Treatment
|
2.65 Preload phase duration in Seconds
Standard Error 0.17
|
.79 Preload phase duration in Seconds
Standard Error .09
|
SECONDARY outcome
Timeframe: Pre-Treatment, Day 90Population: Total upper limb Fugl Meyer scale score out of 66.
This scale has 3 points for each item. A zero 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. Reflex activity is measured using 2 points only, with a score of 0 or 3 for absence and presence of reflex. The maximum total score that can be obtained in Fugl Meyer assessment is 226, though it is common practice to assess all domains separately.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 |
Control (Saline) Group -PRE Treatment
n=6 Participants
Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.
Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study.
|
Botox Group -PRE Treatment
n=10 Participants
A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
There will be 1 treatment cycle during the 9 week study.
|
|---|---|---|
|
Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale
|
47.6 Fugl Meyer Scale Score
Standard Error 4
|
40.7 Fugl Meyer Scale Score
Standard Error 3.31
|
SECONDARY outcome
Timeframe: 90 DaysMeasures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death).
Outcome measures
| Measure |
Control (Saline) Group -PRE Treatment
n=6 Participants
Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.
Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study.
|
Botox Group -PRE Treatment
n=10 Participants
A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
There will be 1 treatment cycle during the 9 week study.
|
|---|---|---|
|
Disability Measured by Modified Rankin Scale Score Post-Treatment
|
2 Modified Rankin Scale Score
Standard Deviation 0.36
|
1.8 Modified Rankin Scale Score
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: 1 Day and 90 DaysPopulation: Total upper limb Fugl Meyer Score out of 66.
Scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities); Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints); Balance (contains 7 tests, 3 seated and 4 standing); Joint range of motion (8 joints); Joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1= perform partially, 2 = perform fully).
Outcome measures
| Measure |
Control (Saline) Group -PRE Treatment
n=6 Participants
Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.
Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study.
|
Botox Group -PRE Treatment
n=10 Participants
A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
There will be 1 treatment cycle during the 9 week study.
|
|---|---|---|
|
Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment
|
52.1 score on a scale
Standard Error 3.5
|
45.5 score on a scale
Standard Error 2.85
|
SECONDARY outcome
Timeframe: Pre-TreatmentMeasures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death).
Outcome measures
| Measure |
Control (Saline) Group -PRE Treatment
n=6 Participants
Some subjects will receive BOTOX® injections. Subject will not be informed of what injection they received.
Botulinum Toxin commonly known as BOTOX®: A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
The control group will receive a placebo injection. There will be 1 treatment cycle during the 9 week study.
|
Botox Group -PRE Treatment
n=10 Participants
A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
There will be 1 treatment cycle during the 9 week study.
|
|---|---|---|
|
Disability Measured by Modified Rankin Scale Score Pre-Treatment
|
2.3 Modified Rankin Scale Score
Standard Deviation .33
|
2.6 Modified Rankin Scale Score
Standard Deviation .33
|
Adverse Events
Botulinum Toxin Commonly Known as BOTOX®
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Preeti Raghavan, MD
New York University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place