Trial Outcomes & Findings for BOTOX® Economic Spasticity Trial (BEST) (NCT NCT00549783)
NCT ID: NCT00549783
Last Updated: 2012-08-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
274 participants
Primary outcome timeframe
Week 24
Results posted on
2012-08-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
135
|
|
Overall Study
COMPLETED
|
131
|
122
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BOTOX® Economic Spasticity Trial (BEST)
Baseline characteristics by cohort
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=135 Participants
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.
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.11 years
n=93 Participants
|
61.86 years
n=4 Participants
|
62.60 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
113 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=93 Participants
|
76 Participants
n=4 Participants
|
161 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=134 Participants
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.
|
|---|---|---|
|
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
|
33.3 Percentage of Patients
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=134 Participants
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.
|
|---|---|---|
|
Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12
|
33.1 Percentage of Patients
|
28.9 Percentage of Patients
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
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
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=134 Participants
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.
|
|---|---|---|
|
Physician Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52
|
45.0 Percentage of Patients
|
52.4 Percentage of Patients
|
SECONDARY outcome
Timeframe: Week 12Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=134 Participants
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.
|
|---|---|---|
|
Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 12
|
33.1 Percentage of Patients
|
27.3 Percentage of Patients
|
SECONDARY outcome
Timeframe: Week 24Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=134 Participants
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.
|
|---|---|---|
|
Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 24
|
40.7 Percentage of Patients
|
39.0 Percentage of Patients
|
SECONDARY outcome
Timeframe: Week 52Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=134 Participants
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.
|
|---|---|---|
|
Patient Assessment of Success, as Determined by Percentage of Patients Who Achieve Their Principal Functional Goal at Week 52
|
48.9 Percentage of Patients
|
50.8 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=134 Participants
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.
|
|---|---|---|
|
Activities of Daily Living Quality of Life (QOL) Score at Week 12
Baseline
|
48.81 Scores on a Scale
Standard Deviation 9.70
|
46.40 Scores on a Scale
Standard Deviation 10.28
|
|
Activities of Daily Living Quality of Life (QOL) Score at Week 12
Week 12
|
51.16 Scores on a Scale
Standard Deviation 9.10
|
49.86 Scores on a Scale
Standard Deviation 9.82
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=134 Participants
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.
|
|---|---|---|
|
Activities of Daily Living Quality of Life (QOL) Score at Week 24
Baseline
|
48.81 Scores on a Scale
Standard Deviation 9.70
|
46.40 Scores on a Scale
Standard Deviation 10.28
|
|
Activities of Daily Living Quality of Life (QOL) Score at Week 24
Week 24
|
52.34 Scores on a Scale
Standard Deviation 10.03
|
49.22 Scores on a Scale
Standard Deviation 10.36
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Intent-to-treat, which consists of all patients who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=139 Participants
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.
|
Placebo
n=134 Participants
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.
|
|---|---|---|
|
Activities of Daily Living Quality of Life (QOL) Score at Week 52
Baseline
|
48.81 Scores on a Scale
Standard Deviation 9.70
|
46.40 Scores on a Scale
Standard Deviation 10.28
|
|
Activities of Daily Living Quality of Life (QOL) Score at Week 52
Week 52
|
51.90 Scores on a Scale
Standard Deviation 9.44
|
50.34 Scores on a Scale
Standard Deviation 10.03
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: Intent-to-treat, which consists of all patients in Canada who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=12 Participants
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.
|
Placebo
n=10 Participants
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.
|
|---|---|---|
|
Direct Costs for Canada
|
18643 Canadian dollar (CAD)
Standard Deviation 15022.4
|
13279 Canadian dollar (CAD)
Standard Deviation 10827.9
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: Intent-to-treat, which consists of all patients in Germany who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=34 Participants
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.
|
Placebo
n=34 Participants
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.
|
|---|---|---|
|
Direct Costs for Germany
|
10181 Euro (EUR)
Standard Deviation 8110.1
|
10346 Euro (EUR)
Standard Deviation 7468.6
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: Intent-to-treat, which consists of all patients in Sweden who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=48 Participants
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.
|
Placebo
n=44 Participants
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.
|
|---|---|---|
|
Direct Costs for Sweden
|
93916 Swedish Krona (SEK)
Standard Deviation 75122.3
|
79580 Swedish Krona (SEK)
Standard Deviation 74951.3
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: Intent-to-treat, which consists of all patients in the United Kingdom who were randomized (started study) and received a baseline injection.
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.
Outcome measures
| Measure |
Botulinum Toxin Type A 900kD
n=45 Participants
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.
|
Placebo
n=46 Participants
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.
|
|---|---|---|
|
Direct Costs for the United Kingdom
|
4671 British Pound (GBP)
Standard Deviation 6116.6
|
3977 British Pound (GBP)
Standard Deviation 4039.2
|
Adverse Events
Botulinum Toxin Type A 900kD
Serious events: 47 serious events
Other events: 60 other events
Deaths: 0 deaths
Placebo
Serious events: 45 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botulinum Toxin Type A 900kD
n=139 participants at risk
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.
|
Placebo
n=134 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
3/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.4%
2/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Blood and lymphatic system disorders
Anaemia Megaloblastic
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
1.5%
2/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Cardiac disorders
Atrial Fibrillation
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Cardiac disorders
Cardiac Failure
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
1.5%
2/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Cardiac disorders
Left Ventricular Failure
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
1.5%
2/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
General disorders
Adverse Drug Reaction
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
General disorders
Non-cardiac Chest Pain
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
General disorders
Pyrexia
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Infections and infestations
Escherichia Infection
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
1.4%
2/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Infections and infestations
Pneumonia
|
1.4%
2/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
3.0%
4/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Infections and infestations
Sepsis
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Infections and infestations
Urinary Tract Infection
|
1.4%
2/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gammopathy
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Cerebral Infarction
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
1.5%
2/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Cognitive Disorder
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Convulsion
|
2.2%
3/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Depressed Level of Consciousness
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Dizziness
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
1.5%
2/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Epilepsy
|
1.4%
2/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
3.0%
4/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Hemiparesis
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Lacunar Infarction
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Muscle Spasticity
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Renal and urinary disorders
Renal Failure
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Reproductive system and breast disorders
Prostatitis
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
1.5%
2/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Vascular disorders
Haematoma
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Vascular disorders
Hypotension
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Vascular disorders
Temporal Arteritis
|
0.72%
1/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.00%
0/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
Other adverse events
| Measure |
Botulinum Toxin Type A 900kD
n=139 participants at risk
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.
|
Placebo
n=134 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.4%
13/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
8.2%
11/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.2%
3/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
6.0%
8/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Infections and infestations
Urinary Tract Infection
|
8.6%
12/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
5.2%
7/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Injury, poisoning and procedural complications
Fall
|
12.9%
18/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
11.2%
15/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
5.0%
7/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
0.75%
1/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.0%
7/139
The Safety Population included all patients who were randomized and received at least 1 injection
|
2.2%
3/134
The Safety Population included all patients who were randomized and received at least 1 injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60