Trial Outcomes & Findings for Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity (NCT NCT01387074)
NCT ID: NCT01387074
Last Updated: 2014-02-03
Results Overview
The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
COMPLETED
108 participants
Baseline
2014-02-03
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin Type A
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Botulinum Toxin Type A
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Observational Study of Botox® Treatment for Patients With Upper Limb Adult Spasticity
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A
n=108 Participants
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Age, Customized
18-30 Years
|
8 Participants
n=5 Participants
|
|
Age, Customized
31-40 Years
|
13 Participants
n=5 Participants
|
|
Age, Customized
41-50 Years
|
22 Participants
n=5 Participants
|
|
Age, Customized
51-60 Years
|
23 Participants
n=5 Participants
|
|
Age, Customized
61-70 Years
|
24 Participants
n=5 Participants
|
|
Age, Customized
71-80 Years
|
14 Participants
n=5 Participants
|
|
Age, Customized
81-90 Years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.
The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=101 Participants
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline
0=No Increase
|
2 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline
1=Slight Increase
|
6 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline
1+=Slight Increase
|
18 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline
2=Marked Increase
|
39 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline
3=Considerable Increase
|
30 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline
4=Affected part rigid
|
6 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.
The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=89 Participants
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24
0=No Increase
|
2 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24
1=Slight Increase
|
26 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24
1+=Slight Increase
|
43 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24
2=Marked Increase
|
12 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24
3=Considerable Increase
|
5 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24
4=Affected part rigid
|
1 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.
The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=101 Participants
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline
0=No Increase
|
3 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline
1=Slight Increase
|
9 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline
1+=Slight Increase
|
16 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline
2=Marked Increase
|
29 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline
3=Considerable Increase
|
35 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline
4=Affected part rigid
|
9 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.
The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=89 Participants
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24
0=No Increase
|
5 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24
1=Slight Increase
|
31 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24
1+=Slight Increase
|
31 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24
2=Marked Increase
|
15 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24
3=Considerable Increase
|
6 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24
4=Affected part rigid
|
1 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.
The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=101 Participants
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline
0=No Increase
|
0 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline
1=Slight Increase
|
5 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline
1+=Slight Increase
|
15 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline
2=Marked Increase
|
20 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline
3=Considerable Increase
|
47 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline
4=Affected part rigid
|
14 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.
The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=89 Participants
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24
0=No Increase
|
4 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24
1=Slight Increase
|
34 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24
1+=Slight Increase
|
27 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24
2=Marked Increase
|
17 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24
3=Considerable Increase
|
5 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24
4=Affected part rigid
|
2 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.
The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=101 Participants
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline
0=No Increase
|
1 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline
1=Slight Increase
|
13 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline
1+=Slight Increase
|
19 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline
2=Marked Increase
|
19 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline
3=Considerable Increase
|
36 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline
4=Affected part rigid
|
13 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.
The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.
Outcome measures
| Measure |
Botulinum Toxin Type A
n=89 Participants
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24
0=No Increase
|
19 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24
1=Slight Increase
|
29 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24
1+=Slight Increase
|
18 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24
2=Marked Increase
|
11 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24
3=Considerable Increase
|
11 Participants
|
|
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24
4=Affected part rigid
|
1 Participants
|
Adverse Events
Botulinum Toxin Type A
Serious adverse events
| Measure |
Botulinum Toxin Type A
n=108 participants at risk
Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
|
|---|---|
|
Nervous system disorders
Status epilepticus
|
0.93%
1/108
|
|
Infections and infestations
Bacteraemia
|
0.93%
1/108
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.93%
1/108
|
|
Gastrointestinal disorders
Gastroenteritis norovirus
|
0.93%
1/108
|
|
Infections and infestations
Clostridium difficile colitis
|
0.93%
1/108
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.93%
1/108
|
|
Endocrine disorders
Type 2 diabetes mellitus
|
0.93%
1/108
|
|
Endocrine disorders
Hypoglycaemia
|
0.93%
1/108
|
|
Renal and urinary disorders
Candiduria
|
0.93%
1/108
|
|
Metabolism and nutrition disorders
Dehydration
|
0.93%
1/108
|
|
General disorders
Death
|
0.93%
1/108
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER