Trial Outcomes & Findings for Dysport® Adult Upper Limb Spasticity (NCT NCT01313299)
NCT ID: NCT01313299
Last Updated: 2022-09-28
Results Overview
MAS scale is used to assess 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 (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
243 participants
Primary outcome timeframe
From Baseline (Day 1) to Week 4
Results posted on
2022-09-28
Participant Flow
This multicenter study was conducted in 34 investigational sites. Subjects screened were 281 and randomised and treated were 243.
Participant milestones
| Measure |
Placebo
Placebo intramuscular injection single treatment cycle on day 1
|
Dysport 500 U
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
|
Dysport 1000 U
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
81
|
81
|
|
Overall Study
COMPLETED
|
74
|
78
|
77
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Placebo intramuscular injection single treatment cycle on day 1
|
Dysport 500 U
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
|
Dysport 1000 U
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
|
Overall Study
Family reason and moved out of state
|
0
|
2
|
0
|
|
Overall Study
Lack of subject compliance
|
0
|
0
|
1
|
Baseline Characteristics
Dysport® Adult Upper Limb Spasticity
Baseline characteristics by cohort
| Measure |
Placebo
n=81 Participants
Placebo intramuscular injection single treatment cycle on day 1
|
Dysport 500 U
n=81 Participants
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
|
Dysport 1000 U
n=81 Participants
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
71 participants
n=5 Participants
|
70 participants
n=7 Participants
|
67 participants
n=5 Participants
|
208 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Ethnicity
Hispanic/Latino
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Ethnicity
Not Hispanic/Latino
|
76 participants
n=5 Participants
|
78 participants
n=7 Participants
|
71 participants
n=5 Participants
|
225 participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
26.78 kg/m2
STANDARD_DEVIATION 5.38 • n=5 Participants
|
27.63 kg/m2
STANDARD_DEVIATION 4.61 • n=7 Participants
|
27.58 kg/m2
STANDARD_DEVIATION 5.51 • n=5 Participants
|
27.33 kg/m2
STANDARD_DEVIATION 5.17 • n=4 Participants
|
|
Modified Ashworth Scale (MAS)
|
3.9 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 0.4 • n=4 Participants
|
|
Disability Assessment Scale (DAS)
|
2.6 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 0.5 • n=7 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 0.5 • n=5 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 0.5 • n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day 1) to Week 4Population: Intention to treat (ITT) population included all randomized subjects who received at least one injection of study drug and had a MAS score at baseline (pretreatment) and at week 4. Total 5 subjects were excluded from ITT population as they did not have MAS score at baseline or/and at week 4.
MAS scale is used to assess 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 (ROM) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.
Outcome measures
| Measure |
Placebo
n=79 Participants
Placebo intramuscular injection single treatment cycle on day 1
|
Dysport 500 U
n=80 Participants
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
|
Dysport 1000 U
n=79 Participants
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
|
|---|---|---|---|
|
Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)
|
-0.3 units on a scale
Standard Deviation 0.6
|
-1.2 units on a scale
Standard Deviation 1.0
|
-1.4 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: At Week 4Population: ITT population. Two subjects each from Placebo and Dysport 1000 U had missed PGA assessment at week 4
PGA is a 9-point scale used to assess global overall treatment response by the investigator (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved).
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo intramuscular injection single treatment cycle on day 1
|
Dysport 500 U
n=80 Participants
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
|
Dysport 1000 U
n=78 Participants
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
|
|---|---|---|---|
|
Physician's Global Assessment (PGA) of Treatment Response
|
0.6 units on a scale
Standard Deviation 1.0
|
1.4 units on a scale
Standard Deviation 1.1
|
1.8 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: From Baseline (Day 1) to Week 4Population: ITT population. Two subjects each from Placebo and Dysport 1000 U had missed DAS assessment at baseline and week 4.
DAS is a 4-point scale used to determine the extent of functional impairment in 4 functional domains (dressing, hygiene, limb position and pain). DAS scale rating: 0=No disability, 1=Mild disability (noticeable but does not interfere significantly with normal activities), 2=Moderate disability (normal activities require increased effort and/or assistance) and 3=Severe disability (normal activities limited). If subject chose 'Hygiene' as PTT the score collected will be between 0 and 3.
Outcome measures
| Measure |
Placebo
n=79 Participants
Placebo intramuscular injection single treatment cycle on day 1
|
Dysport 500 U
n=80 Participants
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
|
Dysport 1000 U
n=79 Participants
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
|
|---|---|---|---|
|
Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)
|
-0.5 units on a scale
Standard Deviation 0.7
|
-0.7 units on a scale
Standard Deviation 0.8
|
-0.7 units on a scale
Standard Deviation 0.7
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Dysport 500 U
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Dysport 1000 U
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=81 participants at risk
Placebo intramuscular injection single treatment cycle on day 1
|
Dysport 500 U
n=81 participants at risk
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
|
Dysport 1000 U
n=81 participants at risk
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
|
|---|---|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Vascular disorders
Behcet's syndrome
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
General disorders
Death
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
Other adverse events
| Measure |
Placebo
n=81 participants at risk
Placebo intramuscular injection single treatment cycle on day 1
|
Dysport 500 U
n=81 participants at risk
Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
|
Dysport 1000 U
n=81 participants at risk
Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
8.6%
7/81 • Number of events 7 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/81 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Infections and infestations
Urinary tract infections
|
0.00%
0/81 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Investigations
Gamma glutamyl transferase increased
|
0.00%
0/81 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/81 • Up to 24±2 weeks
|
3.7%
3/81 • Number of events 3 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
|
Investigations
Blood glucose increased
|
0.00%
0/81 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
4.9%
4/81 • Number of events 4 • Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 4 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
General disorders
Injection site erythema
|
0.00%
0/81 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
|
General disorders
Injection site bruising
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
General disorders
Asthenia
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
General disorders
Injection site pain
|
3.7%
3/81 • Number of events 3 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/81 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 3 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/81 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 3 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/81 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/81 • Up to 24±2 weeks
|
2.5%
2/81 • Number of events 2 • Up to 24±2 weeks
|
1.2%
1/81 • Number of events 1 • Up to 24±2 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/81 • Up to 24±2 weeks
|
3.7%
3/81 • Number of events 3 • Up to 24±2 weeks
|
0.00%
0/81 • Up to 24±2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place