Trial Outcomes & Findings for Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function (NCT NCT00076687)
NCT ID: NCT00076687
Last Updated: 2011-10-03
Results Overview
Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Baseline, Week 6
Results posted on
2011-10-03
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
|
Botulinum Toxin Type A 240 U
botulinum toxin Type A 240 U
|
Botulinum Toxin Type A 360 U
botulinum toxin Type A 360 U
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
52
|
55
|
|
Overall Study
COMPLETED
|
42
|
47
|
51
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
Baseline characteristics by cohort
| Measure |
Placebo
n=48 Participants
Placebo
|
Botulinum Toxin Type A 240 U
n=52 Participants
botulinum toxin Type A 240 U
|
Botulinum Toxin Type A 360 U
n=55 Participants
botulinum toxin Type A 360 U
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
58 years
n=5 Participants
|
55.5 years
n=7 Participants
|
55.8 years
n=5 Participants
|
56.4 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Safety
Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo
|
Botulinum Toxin Type A 240 U
n=52 Participants
botulinum toxin Type A 240 U
|
Botulinum Toxin Type A 360 U
n=55 Participants
botulinum toxin Type A 360 U
|
|---|---|---|---|
|
Change From Baseline in Forced Vital Capacity (FVC)
Baseline
|
2.889 Liters of air
Standard Deviation 0.7804
|
3.068 Liters of air
Standard Deviation 0.8766
|
2.923 Liters of air
Standard Deviation 0.7627
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Change from Baseline at Week 6
|
0.057 Liters of air
Standard Deviation 0.3151
|
0.052 Liters of air
Standard Deviation 0.2883
|
-0.081 Liters of air
Standard Deviation 0.2531
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: Safety
Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo
|
Botulinum Toxin Type A 240 U
n=52 Participants
botulinum toxin Type A 240 U
|
Botulinum Toxin Type A 360 U
n=55 Participants
botulinum toxin Type A 360 U
|
|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume (FEV1)
Baseline
|
2.111 Liters of air
Standard Deviation 0.5944
|
2.223 Liters of air
Standard Deviation 0.6492
|
2.168 Liters of air
Standard Deviation 0.6568
|
|
Change From Baseline in Forced Expiratory Volume (FEV1)
Change from Baseline at Week 6
|
0.049 Liters of air
Standard Deviation 0.1971
|
0.023 Liters of air
Standard Deviation 0.2925
|
-0.008 Liters of air
Standard Deviation 0.2340
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Safety
Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo
|
Botulinum Toxin Type A 240 U
n=52 Participants
botulinum toxin Type A 240 U
|
Botulinum Toxin Type A 360 U
n=55 Participants
botulinum toxin Type A 360 U
|
|---|---|---|---|
|
Change From Baseline in FEV1/FVC Ratio
Baseline
|
0.741 Ratio
Standard Deviation 0.1320
|
0.731 Ratio
Standard Deviation 0.1260
|
0.742 Ratio
Standard Deviation 0.1051
|
|
Change From Baseline in FEV1/FVC Ratio
Change from Baseline at Week 6
|
0.000 Ratio
Standard Deviation 0.0730
|
-0.006 Ratio
Standard Deviation 0.0709
|
0.019 Ratio
Standard Deviation 0.0699
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Intent to Treat
Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement.
Outcome measures
| Measure |
Placebo
n=48 Participants
Placebo
|
Botulinum Toxin Type A 240 U
n=52 Participants
botulinum toxin Type A 240 U
|
Botulinum Toxin Type A 360 U
n=55 Participants
botulinum toxin Type A 360 U
|
|---|---|---|---|
|
Change From Baseline in Ashworth Scale
Baseline
|
3.19 Number on a scale
Standard Deviation 0.607
|
2.87 Number on a scale
Standard Deviation 0.561
|
2.96 Number on a scale
Standard Deviation 0.693
|
|
Change From Baseline in Ashworth Scale
Change from Baseline at Week 6
|
-0.60 Number on a scale
Standard Deviation 0.564
|
-1.01 Number on a scale
Standard Deviation 0.801
|
-1.16 Number on a scale
Standard Deviation 0.834
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 18 other events
Deaths: 0 deaths
Botulinum Toxin Type A 240 U
Serious events: 9 serious events
Other events: 15 other events
Deaths: 0 deaths
Botulinum Toxin Type A 360 U
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=48 participants at risk
Placebo
|
Botulinum Toxin Type A 240 U
n=52 participants at risk
botulinum toxin Type A 240 U
|
Botulinum Toxin Type A 360 U
n=55 participants at risk
botulinum toxin Type A 360 U
|
|---|---|---|---|
|
Infections and infestations
Abscess
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Infections and infestations
Acute endocarditis
|
0.00%
0/48
|
0.00%
0/52
|
1.8%
1/55
|
|
Infections and infestations
Appendicitis
|
0.00%
0/48
|
0.00%
0/52
|
1.8%
1/55
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Infections and infestations
Cellulitis
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/48
|
0.00%
0/52
|
1.8%
1/55
|
|
Infections and infestations
Pneumonia
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Infections and infestations
Splenic abscess
|
2.1%
1/48
|
0.00%
0/52
|
0.00%
0/55
|
|
Infections and infestations
Wound infection
|
2.1%
1/48
|
0.00%
0/52
|
0.00%
0/55
|
|
Nervous system disorders
Convulsion
|
2.1%
1/48
|
0.00%
0/52
|
3.6%
2/55
|
|
Nervous system disorders
Cerebral infarction
|
2.1%
1/48
|
0.00%
0/52
|
0.00%
0/55
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Nervous system disorders
Encephalitis
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Nervous system disorders
Syncope
|
2.1%
1/48
|
0.00%
0/52
|
0.00%
0/55
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Cardiac disorders
Angina Pectoris
|
2.1%
1/48
|
0.00%
0/52
|
0.00%
0/55
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/48
|
0.00%
0/52
|
1.8%
1/55
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.1%
1/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/48
|
0.00%
0/52
|
1.8%
1/55
|
|
Vascular disorders
Hypotension
|
2.1%
1/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Vascular disorders
Hypertension
|
0.00%
0/48
|
0.00%
0/52
|
1.8%
1/55
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.1%
1/48
|
0.00%
0/52
|
0.00%
0/55
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.1%
1/48
|
0.00%
0/52
|
1.8%
1/55
|
|
Blood and lymphatic system disorders
Anaemia
|
2.1%
1/48
|
0.00%
0/52
|
0.00%
0/55
|
|
Congenital, familial and genetic disorders
Meningocele
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
General disorders
Chest pain
|
0.00%
0/48
|
0.00%
0/52
|
1.8%
1/55
|
|
Investigations
Heart rate decreased
|
0.00%
0/48
|
1.9%
1/52
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
2.1%
1/48
|
0.00%
0/52
|
0.00%
0/55
|
|
Renal and urinary disorders
Renal failure
|
2.1%
1/48
|
0.00%
0/52
|
0.00%
0/55
|
Other adverse events
| Measure |
Placebo
n=48 participants at risk
Placebo
|
Botulinum Toxin Type A 240 U
n=52 participants at risk
botulinum toxin Type A 240 U
|
Botulinum Toxin Type A 360 U
n=55 participants at risk
botulinum toxin Type A 360 U
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
4/48
|
1.9%
1/52
|
3.6%
2/55
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
3/48
|
1.9%
1/52
|
1.8%
1/55
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
3/48
|
7.7%
4/52
|
10.9%
6/55
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
1/48
|
0.00%
0/52
|
5.5%
3/55
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
2/48
|
5.8%
3/52
|
3.6%
2/55
|
|
Nervous system disorders
Headache
|
6.2%
3/48
|
0.00%
0/52
|
5.5%
3/55
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/48
|
5.8%
3/52
|
0.00%
0/55
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
2/48
|
5.8%
3/52
|
0.00%
0/55
|
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