Trial Outcomes & Findings for Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression (NCT NCT02321436)
NCT ID: NCT02321436
Last Updated: 2022-09-28
Results Overview
The appearance of increased muscle tone was assessed using the MAS (scale ranges from 0 \[no increase in muscle tone\] to 4 \[affected part rigid in flexion or extension\]). For confirmation of reinjection criteria appearance, a subject had to have a MAS score in the primary targeted muscle group of ≥2 and at least 1 of the following 4 criteria confirming signs of symptomatic spasticity in the UL: 1. A Numeric Pain Rating Scale (NPRS) pain score ≥ 4 (NPRS ranges from 0 \[no pain\] to 10 \[severe pain\]) 2. An impact on passive function measured by a score of ≥ 1 on the 4-point Likert scale (scale ranges from 0 \[no impact\] to 3 \[severe impact\]) 3. An impact on active function measured by a score of ≥ 1 on the 4-point Likert scale 4. An involuntary movements score ≥1 on the 4-point Likert scale in relevant upper limb. Results are reported overall for subjects with both symptomatic and asymptomatic spasticity.
COMPLETED
PHASE4
42 participants
From Week 4 up to Week 28
2022-09-28
Participant Flow
A total of 42 adult subjects with upper limb (UL) spasticity were enrolled into a multicentre, prospective, double-bind, randomised, placebo-controlled pilot study, conducted in four countries (Malaysia, Thailand, Singapore, and the Philippines).
The first visit was scheduled within 2 to 12 weeks post-stroke and subjects were randomized at a ratio of 2:1 to receive either Dysport® 500 Units (U) or placebo. Dysport® was expected to have a beneficial effect in these subjects so the unbalanced randomisation ratio was chosen in order to expose the minimum number of subjects to inactive placebo.
Participant milestones
| Measure |
Dysport ® 500 U
Dysport® 500 U was administered at the clinic in a single intramuscular (IM) injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 millilitre (mL).
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
14
|
|
Overall Study
COMPLETED
|
27
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Dysport ® 500 U
Dysport® 500 U was administered at the clinic in a single intramuscular (IM) injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 millilitre (mL).
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression
Baseline characteristics by cohort
| Measure |
Dysport ® 500 U
n=28 Participants
Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
n=14 Participants
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Total Title
n=42 Participants
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 13.2 • n=93 Participants
|
56.5 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
59.8 years
STANDARD_DEVIATION 12.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
28 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Country
Malaysia
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Country
Philippines
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Country
Singapore
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Country
Thailand
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From Week 4 up to Week 28Population: This analysis was performed on the Intention-To-Treat (ITT) population which includes all randomised subjects who provided informed consent.
The appearance of increased muscle tone was assessed using the MAS (scale ranges from 0 \[no increase in muscle tone\] to 4 \[affected part rigid in flexion or extension\]). For confirmation of reinjection criteria appearance, a subject had to have a MAS score in the primary targeted muscle group of ≥2 and at least 1 of the following 4 criteria confirming signs of symptomatic spasticity in the UL: 1. A Numeric Pain Rating Scale (NPRS) pain score ≥ 4 (NPRS ranges from 0 \[no pain\] to 10 \[severe pain\]) 2. An impact on passive function measured by a score of ≥ 1 on the 4-point Likert scale (scale ranges from 0 \[no impact\] to 3 \[severe impact\]) 3. An impact on active function measured by a score of ≥ 1 on the 4-point Likert scale 4. An involuntary movements score ≥1 on the 4-point Likert scale in relevant upper limb. Results are reported overall for subjects with both symptomatic and asymptomatic spasticity.
Outcome measures
| Measure |
Dysport ® 500 U
n=28 Participants
Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
n=14 Participants
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms
|
156 days
Interval 86.0 to 206.0
|
32 days
Interval 29.0 to 114.0
|
SECONDARY outcome
Timeframe: From baseline up to Week 28Population: This analysis was performed on the ITT population which includes all randomised subjects who provided informed consent.
Increased muscle tone in the primary muscle group (selected by the investigator at the first visit, based on his/her clinical judgement and in agreement with the subject, in one of the following muscle groups: elbow flexors or pronators, wrist flexors, or finger flexors) was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Least Squares (LS) mean change from baseline to each subsequent visit (including the subject's last study visit) of the MAS score is reported.
Outcome measures
| Measure |
Dysport ® 500 U
n=28 Participants
Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
n=14 Participants
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Mean Change in MAS of the Primary Targeted Muscle Group.
Visit 2 (Week 4)
|
-1.27 units on a scale
Standard Error 0.17
|
-0.26 units on a scale
Standard Error 0.22
|
|
Mean Change in MAS of the Primary Targeted Muscle Group.
Visit 3 (Week 6)
|
-1.29 units on a scale
Standard Error 0.19
|
-0.24 units on a scale
Standard Error 0.24
|
|
Mean Change in MAS of the Primary Targeted Muscle Group.
Visit 4 (Week 8)
|
-1.29 units on a scale
Standard Error 0.18
|
-0.24 units on a scale
Standard Error 0.24
|
|
Mean Change in MAS of the Primary Targeted Muscle Group.
Visit 5 (Week 10)
|
-1.06 units on a scale
Standard Error 0.17
|
-0.22 units on a scale
Standard Error 0.22
|
|
Mean Change in MAS of the Primary Targeted Muscle Group.
Visit 6 (Week12)
|
-0.86 units on a scale
Standard Error 0.18
|
-0.03 units on a scale
Standard Error 0.24
|
|
Mean Change in MAS of the Primary Targeted Muscle Group.
Visit 7 (Week 16)
|
-1.14 units on a scale
Standard Error 0.18
|
-0.63 units on a scale
Standard Error 0.35
|
|
Mean Change in MAS of the Primary Targeted Muscle Group.
Visit 8 (Week 20)
|
-0.9 units on a scale
Standard Error 0.19
|
-0.75 units on a scale
Standard Error 0.47
|
|
Mean Change in MAS of the Primary Targeted Muscle Group.
Visit 9 (Week 24)
|
-0.87 units on a scale
Standard Error 0.24
|
-0.75 units on a scale
Standard Error 0.57
|
|
Mean Change in MAS of the Primary Targeted Muscle Group.
Visit 10 (Week 28)
|
-0.96 units on a scale
Standard Error 0.2
|
-0.75 units on a scale
Standard Error 0.42
|
SECONDARY outcome
Timeframe: From baseline up to Week 28Population: This analysis was performed on the ITT population and includes all randomised subjects who provided informed consent.
The Fugl-Meyer assessment is a validated tool for measuring motor functioning, balance, sensation, and joint functioning in the upper or lower limbs of subjects with post-stroke hemiplegia. The assessment scale is comprised of 155 items across 5 domains: motor functioning, sensory functioning, balance, joint range of motion and joint pain. For this study, only the UL motor part was assessed using the following criteria: A. Upper Extremity (from 0 to 36) B. Wrist (from 0 to 10) C. Hand (from 0 to 14) D. Coordination / Speed (from 0 to 6) Total motor function scores (A-D \[from 0 to 66\]) were calculated and LS mean changes from baseline up to (but not including) the visit when the reinjection criteria were met were reported. Higher values for change from baseline indicated a better outcome.
Outcome measures
| Measure |
Dysport ® 500 U
n=28 Participants
Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
n=14 Participants
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
Visit 2 (Week 4)
|
6.4 units on a scale
Standard Error 2.5
|
5.6 units on a scale
Standard Error 4.4
|
|
Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
Visit 3 (Week 6)
|
7.4 units on a scale
Standard Error 2.6
|
8.3 units on a scale
Standard Error 5.0
|
|
Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
Visit 4 (Week 8)
|
6.9 units on a scale
Standard Error 2.6
|
9.2 units on a scale
Standard Error 5.0
|
|
Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
Visit 5 (Week 10)
|
10.3 units on a scale
Standard Error 2.9
|
10.4 units on a scale
Standard Error 5.4
|
|
Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
Visit 6 (Week 12)
|
11.1 units on a scale
Standard Error 3.5
|
6.5 units on a scale
Standard Error 6.9
|
|
Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
Visit 7 (Week 16)
|
9.4 units on a scale
Standard Error 3.7
|
21.8 units on a scale
Standard Error 9.2
|
|
Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
Visit 8 (Week 20)
|
9.4 units on a scale
Standard Error 4.4
|
23.5 units on a scale
Standard Error 10.5
|
|
Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
Visit 9 (Week 24)
|
14.8 units on a scale
Standard Error 4.6
|
23.8 units on a scale
Standard Error 9.8
|
|
Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.
Visit 10 (Week 28)
|
15.0 units on a scale
Standard Error 5.4
|
19.5 units on a scale
Standard Error 11.5
|
SECONDARY outcome
Timeframe: From Week 4 up to Week 28Population: This efficacy analysis was performed on the ITT population which includes all randomised subjects who provided informed consent. No data is available for subjects who met their reinjection criteria at Visit 2 (Week 4).
Global assessment of changes was assessed by the investigator from Week 4 up to (but not including) the visit when the reinjection criteria were met. This endpoint was assessed by the investigator using a 5-point Likert scale to answer the following question: How does your patient feel compared to his/her condition at the first visit? * Much better * Better * No change * Worse * Much worse Results are reported overall for subjects with both symptomatic and asymptomatic spasticity.
Outcome measures
| Measure |
Dysport ® 500 U
n=22 Participants
Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
n=6 Participants
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Global Assessment of Changes at Last Visit
Much Better
|
9.1 percentage of participants
|
0 percentage of participants
|
|
Global Assessment of Changes at Last Visit
Better
|
81.8 percentage of participants
|
83.3 percentage of participants
|
|
Global Assessment of Changes at Last Visit
No Change
|
4.5 percentage of participants
|
16.7 percentage of participants
|
|
Global Assessment of Changes at Last Visit
Worse
|
4.5 percentage of participants
|
0 percentage of participants
|
|
Global Assessment of Changes at Last Visit
Much Worse
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From baseline up to Week 28Population: This analysis was performed on the safety population which includes all randomised subjects who received the study medication.
The number of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). All concomitant therapies in the indication of "Post Stroke UL Spasticity" were counted by subject from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date.
Outcome measures
| Measure |
Dysport ® 500 U
n=28 Participants
Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
n=14 Participants
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Number of Concomitant Non-drug Therapy Sessions.
Any concomitant non-drug therapies
|
25 Number of sessions
|
14 Number of sessions
|
|
Number of Concomitant Non-drug Therapy Sessions.
Physiotherapy
|
22 Number of sessions
|
14 Number of sessions
|
|
Number of Concomitant Non-drug Therapy Sessions.
Other therapies
|
8 Number of sessions
|
5 Number of sessions
|
SECONDARY outcome
Timeframe: From baseline up to Week 28Population: This analysis was performed on the safety population which includes all randomised subjects who received the study medication.
The duration of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). Overall duration of concomitant therapies in the indication of "Post Stroke UL Spasticity" was computed for the period from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date.
Outcome measures
| Measure |
Dysport ® 500 U
n=28 Participants
Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5 mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
n=14 Participants
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Mean Duration of Concomitant Non-drug Therapy Sessions.
Any concomitant non-drug therapies
|
160.5 days
Standard Deviation 56.8
|
126.1 days
Standard Deviation 55.0
|
|
Mean Duration of Concomitant Non-drug Therapy Sessions.
Physiotherapy
|
157.9 days
Standard Deviation 59.2
|
126.1 days
Standard Deviation 55.0
|
|
Mean Duration of Concomitant Non-drug Therapy Sessions.
Other therapies
|
184.9 days
Standard Deviation 41.3
|
154.6 days
Standard Deviation 84.4
|
Adverse Events
Dysport ® 500 U
Placebo
Serious adverse events
| Measure |
Dysport ® 500 U
n=28 participants at risk
Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
n=14 participants at risk
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
7.1%
2/28 • Number of events 2 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
Other adverse events
| Measure |
Dysport ® 500 U
n=28 participants at risk
Dysport® 500 U was administered at the clinic in a single IM injection in the targeted UL. The investigator was allowed to adjust the dose per targeted muscle, depending on the level of hypertonicity, as long as the total fixed dosage per subject was 500 U/2.5mL.
Evaluation of reinjection criteria started at Week 4 post-injection of Dysport®. Assessments were then performed every 2 weeks until Week 12, Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
Placebo
n=14 participants at risk
Placebo was administered at the clinic in a single IM injection in the targeted UL. Evaluation of reinjection criteria started at Week 4 post-injection of placebo. Assessments were then performed every 2 weeks until Week 12. Following Week 12, assessments were performed every 4 weeks until Week 28. The subject's last study visit was the visit when reinjection criteria was met, Week 28, or early withdrawal visit.
|
|---|---|---|
|
Cardiac disorders
Tachycardia
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
General disorders
Pain
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
General disorders
Pyrexia
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
7.1%
1/14 • Number of events 2 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
7.1%
1/14 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
7.1%
1/14 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/28 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
7.1%
1/14 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Psychiatric disorders
Insomnia
|
7.1%
2/28 • Number of events 2 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/28 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
7.1%
1/14 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
|
Vascular disorders
Hypertensive crisis
|
3.6%
1/28 • Number of events 1 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
0.00%
0/14 • Up to Week 28.
Treatment Emergent Adverse Events (TEAEs) were reported and defined as any Adverse Event (AE) that emerged or worsened during the active phase of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the first communication or publication regarding the study must be a joint publication between the PI and Sponsor.
- Publication restrictions are in place
Restriction type: OTHER