Muscle Spasticity
Conditions
Brief summary
This is a study to investigate if patients who have had a stroke and suffer from spasticity might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to reduce spasticity significantly. Patients will be enrolled in this study at about 33 locations in Europe and Canada. Study participation will last for about 1 year.
Interventions
BIOLOGICALBotulinum Toxin Type A 900kD
The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness. First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
BIOLOGICALPlacebo
The exact dosage and number of injection sites is based on the size, number, and location of muscles involved; the severity of spasticity; and the presence of local muscle weakness. First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients with stroke due to a primary cerebral hemorrhage/infarction * Subarachnoid hemorrhage producing an upper motor syndrome affecting one body side which results in a hemi-paralysis/plegia
Exclusion criteria
* Patients with fixed contracture as a result of spasticity in the upper or lower limb planned to be treated and/or patients with other causes of spasticity (e.g. multiple sclerosis, spinal cord injury, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24 | Week 24 | Physician assessment of success, as determined by percentage of patients who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | Week 52 | Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected |
| Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | Week 12 | Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 12. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. |
| Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24 | Week 24 | Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. |
| Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | Week 52 | Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. |
| Activities of Daily Living Quality of Life (QOL) Score at Week 12 | Baseline, Week 12 | Activities of Daily Living QOL score at week 12 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state. |
| Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | Week 12 | Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 12. The GAS is 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected. |
| Activities of Daily Living Quality of Life (QOL) Score at Week 52 | Baseline, Week 52 | Activities of daily living QOL score at week 52 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state. |
| Direct Costs for Canada | 52 Weeks | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Canada. |
| Direct Costs for Germany | 52 Weeks | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Germany. |
| Direct Costs for Sweden | 52 Weeks | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Sweden. |
| Direct Costs for the United Kingdom | 52 Weeks | Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for the United Kingdom. |
| Activities of Daily Living Quality of Life (QOL) Score at Week 24 | Baseline, Week 24 | Activities of daily living QOL score at week 24 (or 10 weeks post second injection) as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state. |
Countries
Canada, Germany, Sweden, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A 900kD First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. | 139 |
| Placebo First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit. | 135 |
| Total | 274 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A 900kD | Placebo | Total |
|---|---|---|---|
| Age Continuous | 64.11 years | 61.86 years | 62.60 years |
| Sex: Female, Male Female | 54 Participants | 59 Participants | 113 Participants |
| Sex: Female, Male Male | 85 Participants | 76 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 139 | 45 / 134 |
| serious Total, serious adverse events | 47 / 139 | 45 / 134 |
Outcome results
Primary
Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24
Physician assessment of success, as determined by percentage of patients who achieve their principal active functional goal (i.e. a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.
Time frame: Week 24
Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 900kD | Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24 | 40.9 Percentage of Patients |
| Placebo | Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Active Functional Goal at Week 24 | 33.3 Percentage of Patients |
Secondary
Activities of Daily Living Quality of Life (QOL) Score at Week 12
Activities of Daily Living QOL score at week 12 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.
Time frame: Baseline, Week 12
Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 900kD | Activities of Daily Living Quality of Life (QOL) Score at Week 12 | Baseline | 48.81 Scores on a Scale | Standard Deviation 9.7 |
| Botulinum Toxin Type A 900kD | Activities of Daily Living Quality of Life (QOL) Score at Week 12 | Week 12 | 51.16 Scores on a Scale | Standard Deviation 9.1 |
| Placebo | Activities of Daily Living Quality of Life (QOL) Score at Week 12 | Baseline | 46.40 Scores on a Scale | Standard Deviation 10.28 |
| Placebo | Activities of Daily Living Quality of Life (QOL) Score at Week 12 | Week 12 | 49.86 Scores on a Scale | Standard Deviation 9.82 |
Secondary
Activities of Daily Living Quality of Life (QOL) Score at Week 24
Activities of daily living QOL score at week 24 (or 10 weeks post second injection) as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.
Time frame: Baseline, Week 24
Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 900kD | Activities of Daily Living Quality of Life (QOL) Score at Week 24 | Baseline | 48.81 Scores on a Scale | Standard Deviation 9.7 |
| Botulinum Toxin Type A 900kD | Activities of Daily Living Quality of Life (QOL) Score at Week 24 | Week 24 | 52.34 Scores on a Scale | Standard Deviation 10.03 |
| Placebo | Activities of Daily Living Quality of Life (QOL) Score at Week 24 | Baseline | 46.40 Scores on a Scale | Standard Deviation 10.28 |
| Placebo | Activities of Daily Living Quality of Life (QOL) Score at Week 24 | Week 24 | 49.22 Scores on a Scale | Standard Deviation 10.36 |
Secondary
Activities of Daily Living Quality of Life (QOL) Score at Week 52
Activities of daily living QOL score at week 52 as measured by SF-12 Physical Component (PCS-12). The SF-12 consists of 12 questions on various health questions. The PCS-12 is a sub-score calculated from the SF-12 total score based on the physical health questions where 0 is worse and 100 is best. A higher score indicates a better health state.
Time frame: Baseline, Week 52
Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A 900kD | Activities of Daily Living Quality of Life (QOL) Score at Week 52 | Baseline | 48.81 Scores on a Scale | Standard Deviation 9.7 |
| Botulinum Toxin Type A 900kD | Activities of Daily Living Quality of Life (QOL) Score at Week 52 | Week 52 | 51.90 Scores on a Scale | Standard Deviation 9.44 |
| Placebo | Activities of Daily Living Quality of Life (QOL) Score at Week 52 | Baseline | 46.40 Scores on a Scale | Standard Deviation 10.28 |
| Placebo | Activities of Daily Living Quality of Life (QOL) Score at Week 52 | Week 52 | 50.34 Scores on a Scale | Standard Deviation 10.03 |
Secondary
Direct Costs for Canada
Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Canada.
Time frame: 52 Weeks
Population: Intent-to-treat, which consists of all patients in Canada who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin Type A 900kD | Direct Costs for Canada | 18643 Canadian dollar (CAD) | Standard Deviation 15022.4 |
| Placebo | Direct Costs for Canada | 13279 Canadian dollar (CAD) | Standard Deviation 10827.9 |
Secondary
Direct Costs for Germany
Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Germany.
Time frame: 52 Weeks
Population: Intent-to-treat, which consists of all patients in Germany who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin Type A 900kD | Direct Costs for Germany | 10181 Euro (EUR) | Standard Deviation 8110.1 |
| Placebo | Direct Costs for Germany | 10346 Euro (EUR) | Standard Deviation 7468.6 |
Secondary
Direct Costs for Sweden
Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for Sweden.
Time frame: 52 Weeks
Population: Intent-to-treat, which consists of all patients in Sweden who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin Type A 900kD | Direct Costs for Sweden | 93916 Swedish Krona (SEK) | Standard Deviation 75122.3 |
| Placebo | Direct Costs for Sweden | 79580 Swedish Krona (SEK) | Standard Deviation 74951.3 |
Secondary
Direct Costs for the United Kingdom
Direct healthcare costs associated with spasticity in cases where the primary reason for the use of the identified health care resource was the treatment of spasticity, or any related complications. Direct healthcare costs are presented in the local currency for the United Kingdom.
Time frame: 52 Weeks
Population: Intent-to-treat, which consists of all patients in the United Kingdom who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botulinum Toxin Type A 900kD | Direct Costs for the United Kingdom | 4671 British Pound (GBP) | Standard Deviation 6116.6 |
| Placebo | Direct Costs for the United Kingdom | 3977 British Pound (GBP) | Standard Deviation 4039.2 |
Secondary
Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12
Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 12. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.
Time frame: Week 12
Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 900kD | Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | 33.1 Percentage of Patients |
| Placebo | Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | 27.3 Percentage of Patients |
Secondary
Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24
Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 24 (or 10 weeks post second injection). The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.
Time frame: Week 24
Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 900kD | Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24 | 40.7 Percentage of Patients |
| Placebo | Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24 | 39.0 Percentage of Patients |
Secondary
Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52
Patient assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.
Time frame: Week 52
Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 900kD | Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | 48.9 Percentage of Patients |
| Placebo | Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | 50.8 Percentage of Patients |
Secondary
Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12
Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 12. The GAS is 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected.
Time frame: Week 12
Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 900kD | Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | 33.1 Percentage of Patients |
| Placebo | Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12 | 28.9 Percentage of Patients |
Secondary
Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52
Physician assessment of success, as determined by percentage of patients who achieve their principal functional goal (i.e., a score of 0 to +2 inclusive on the goal attainment scale \[GAS\]) at week 52. The GAS is a 6-point scale where -3 means function is worse than at start, 0 means the expected goal was attained, and +2 is much better function than expected
Time frame: Week 52
Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Botulinum Toxin Type A 900kD | Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | 45.0 Percentage of Patients |
| Placebo | Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52 | 52.4 Percentage of Patients |