Trial Outcomes & Findings for Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin A Alone in Treatment of Post-stroke Spasticity (NCT NCT00945295)
NCT ID: NCT00945295
Last Updated: 2013-11-01
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
6 Weeks
Results posted on
2013-11-01
Participant Flow
Thirty one patients with post-stroke upper limb spasticity aged 36 - 75 years were enrolled. Patients were recruited from neurology clinics and through local advertisements.
At the time of consent, all participants agreed that if they were assigned to the BoNT-A no rehab, they would not to start any new therapy or exercise program for arm spasticity until they were finished with the study.
Participant milestones
| Measure |
Cohort #1
Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
Cohort #2
Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin A Alone in Treatment of Post-stroke Spasticity
Baseline characteristics by cohort
| Measure |
Cohort #1
n=15 Participants
Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
Cohort #2
n=16 Participants
Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
Total
n=31 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
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age Continuous
|
58.0 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
59.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 WeeksOutcome measures
| Measure |
Cohort #1
n=15 Participants
Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
Cohort #2
n=16 Participants
Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
|---|---|---|
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The Maximum Change in Fugl-Meyer Upper Extremity Score From the Baseline Exam to Any Post Injection Visit in Each Treatment Arm. Comparison of the Difference Scores Between the Two Groups Will be Considered Significant at p < 0.05.
|
6.86 difference
|
3.55 difference
|
SECONDARY outcome
Timeframe: 6 WeeksOutcome measures
| Measure |
Cohort #1
n=15 Participants
Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
Cohort #2
n=16 Participants
Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
|---|---|---|
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Length of Time to Meet Re-injection Criteria and the Number of Participants That do Not Meet Re-injection Criteria Prior to Completion of the Study.
|
4 number
|
1 number
|
Adverse Events
Cohort #1
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort #2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort #1
n=15 participants at risk
Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
Cohort #2
n=16 participants at risk
Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
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|---|---|---|
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Nervous system disorders
hospitalization
|
20.0%
3/15 • Number of events 3
|
12.5%
2/16 • Number of events 2
|
Other adverse events
| Measure |
Cohort #1
n=15 participants at risk
Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).
Rehabilitation Therapy : Rehabilitation therapy
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
Cohort #2
n=16 participants at risk
Cohort 2 will receive BoNT-A alone
Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis).
|
|---|---|---|
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Nervous system disorders
seizures
|
13.3%
2/15 • Number of events 2
|
0.00%
0/16
|
|
Infections and infestations
infection
|
40.0%
6/15 • Number of events 6
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
anemia
|
13.3%
2/15 • Number of events 2
|
0.00%
0/16
|
|
General disorders
pain
|
0.00%
0/15
|
12.5%
2/16 • Number of events 2
|
Additional Information
JoAnn Harnar, Research Nurse
New Mexico VA Healthcare System
Phone: 505-256-5701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place