Muscle Spasticity
Conditions
Brief summary
This is a prospective, non-interventional, observational study to collect data on the use of botulinum toxin Type A in a routine setting in patients with upper limb adult spasticity.
Interventions
BIOLOGICALbotulinum 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.
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with upper limb spasticity following a stroke * Eligible to receive botulinum toxin Type A * No previous botulinum toxin Type A therapy
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | Baseline | 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. |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | Week 24 | 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. |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline | Baseline | 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. |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 | Week 24 | 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. |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline | Baseline | 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. |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 | Week 24 | 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. |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline | Baseline | 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. |
| Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 | Week 24 | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A |
|---|---|
| Age, Customized 18-30 Years | 8 Participants |
| Age, Customized 31-40 Years | 13 Participants |
| Age, Customized 41-50 Years | 22 Participants |
| Age, Customized 51-60 Years | 23 Participants |
| Age, Customized 61-70 Years | 24 Participants |
| Age, Customized 71-80 Years | 14 Participants |
| Age, Customized 81-90 Years | 4 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 108 |
| serious Total, serious adverse events | 1 / 108 |
Outcome results
Primary
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline
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.
Time frame: Baseline
Population: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | 0=No Increase | 2 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | 1=Slight Increase | 6 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | 1+=Slight Increase | 18 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | 2=Marked Increase | 39 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | 3=Considerable Increase | 30 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline | 4=Affected part rigid | 6 Participants |
Primary
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24
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.
Time frame: Week 24
Population: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | 0=No Increase | 2 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | 1=Slight Increase | 26 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | 1+=Slight Increase | 43 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | 2=Marked Increase | 12 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | 3=Considerable Increase | 5 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24 | 4=Affected part rigid | 1 Participants |
Primary
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline
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.
Time frame: Baseline
Population: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline | 0=No Increase | 0 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline | 1=Slight Increase | 5 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline | 1+=Slight Increase | 15 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline | 2=Marked Increase | 20 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline | 3=Considerable Increase | 47 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline | 4=Affected part rigid | 14 Participants |
Primary
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24
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.
Time frame: Week 24
Population: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 | 0=No Increase | 4 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 | 1=Slight Increase | 34 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 | 1+=Slight Increase | 27 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 | 2=Marked Increase | 17 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 | 3=Considerable Increase | 5 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24 | 4=Affected part rigid | 2 Participants |
Primary
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline
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.
Time frame: Baseline
Population: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline | 0=No Increase | 1 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline | 1=Slight Increase | 13 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline | 1+=Slight Increase | 19 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline | 2=Marked Increase | 19 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline | 3=Considerable Increase | 36 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline | 4=Affected part rigid | 13 Participants |
Primary
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24
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.
Time frame: Week 24
Population: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 | 0=No Increase | 19 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 | 1=Slight Increase | 29 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 | 1+=Slight Increase | 18 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 | 2=Marked Increase | 11 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 | 3=Considerable Increase | 11 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24 | 4=Affected part rigid | 1 Participants |
Primary
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline
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.
Time frame: Baseline
Population: Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline | 0=No Increase | 3 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline | 1=Slight Increase | 9 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline | 1+=Slight Increase | 16 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline | 2=Marked Increase | 29 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline | 3=Considerable Increase | 35 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline | 4=Affected part rigid | 9 Participants |
Primary
Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24
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.
Time frame: Week 24
Population: Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 | 0=No Increase | 5 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 | 1=Slight Increase | 31 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 | 1+=Slight Increase | 31 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 | 2=Marked Increase | 15 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 | 3=Considerable Increase | 6 Participants |
| Botulinum Toxin Type A | Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24 | 4=Affected part rigid | 1 Participants |