Trial Outcomes & Findings for Comparing Lower-concentration Dysport Treatment Targeted to the Neuromuscular Junction With Current Clinical Practice (NCT NCT01682148)

Last Updated: 2022-09-27

Results Overview

A clinically relevant change was one level decrease on the MAS scale. Subjects meeting the defined decrease at Week 4 were considered as responders in the primary efficacy analysis.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

Baseline to Week 4

Results posted on

2022-09-27

Participant Flow

From September 2012, subjects were recruited across 20 sites in four countries: Denmark (5 sites), Finland (2 sites), Norway (2 sites) and Sweden (11 sites). Due to slow recruitment, the study was terminated early.

272 subjects were planned to be randomised (136 subjects in each group). In total, 100 subjects were enrolled and 88 (44 subjects in each group) were randomised and received study medication; 12 subjects were screening failures.

Participant milestones

Participant milestones
Measure	NMJ Targeted Neuromuscular junction (NMJ) targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Overall Study STARTED	44	44
Overall Study COMPLETED	40	41
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	NMJ Targeted Neuromuscular junction (NMJ) targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	1	2
Overall Study Protocol Violation	1	1

Baseline Characteristics

Comparing Lower-concentration Dysport Treatment Targeted to the Neuromuscular Junction With Current Clinical Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NMJ Targeted n=44 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice n=44 Participants Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Total n=88 Participants Total of all reporting groups
Age, Customized	57.1 years STANDARD_DEVIATION 11.4 • n=5 Participants	60.3 years STANDARD_DEVIATION 14.4 • n=7 Participants	58.7 years STANDARD_DEVIATION 13.0 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment Sweden	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment Norway	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Finland	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Denmark	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 4

Population: The primary analysis was based on both the ITT and Per Protocol (PP) populations. The ITT population was all treated subjects having at least one Baseline assessment of the primary efficacy parameter. The PP population was all subjects in the ITT population for whom no major protocol violations or deviations occurred until Week 4 (Visit 2).

A clinically relevant change was one level decrease on the MAS scale. Subjects meeting the defined decrease at Week 4 were considered as responders in the primary efficacy analysis.

Outcome measures

Outcome measures
Measure	NMJ Targeted (ITT Population) n=44 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (ITT Population) n=44 Participants Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	NMJ Targeted (PP Population) n=25 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (PP Population) n=29 Participants Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Change From Baseline for Elbow Flexors Muscle Tone as Measured by the Modified Ashworth Scale (MAS) at Week 4	25 responders	32 responders	17 responders	20 responders

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in this analysis. CCP=Current Clinical Practice; N'=number of subjects with data at each time point for each treatment group; NMJ=neuromuscular junction.

Increased muscle tone in elbow flexors was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).

Outcome measures

Outcome measures
Measure	NMJ Targeted (ITT Population) n=40 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (ITT Population) n=43 Participants Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	NMJ Targeted (PP Population) NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (PP Population) Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Change From Baseline for Elbow Flexors Muscle Tone as Measured by the Modified Ashworth Scale (MAS) at Week 4 and Week 12 Baseline to Week 4	-0.5 units on a scale Interval -2.0 to 1.0	-1.0 units on a scale Interval -3.0 to 1.0	—	—
Change From Baseline for Elbow Flexors Muscle Tone as Measured by the Modified Ashworth Scale (MAS) at Week 4 and Week 12 Baseline to Week 12	0.0 units on a scale Interval -2.0 to 1.0	0.0 units on a scale Interval -2.0 to 1.0	—	—

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in the analysis.

A clinically relevant change was one level decrease on the MAS scale. Subjects meeting the defined decrease at Week 12 were considered as responders.

Outcome measures

Outcome measures
Measure	NMJ Targeted (ITT Population) n=39 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (ITT Population) n=39 Participants Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	NMJ Targeted (PP Population) NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (PP Population) Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Change From Baseline for Elbow Flexors Muscle Tone as Measured by the MAS at Week 12	13 responders	19 responders	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 12

Population: ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. CCP=Current Clinical Practice; N'=number of subjects with data at each time point for each treatment group; NMJ=neuromuscular junction.

Pain assessment using the VAS. The VAS was a 10 cm straight horizontal line scoring scale. Score range on VAS was from 0 to 10 where 0 indicated no pain and 10 indicated worst pain imaginable.

Outcome measures

Outcome measures
Measure	NMJ Targeted (ITT Population) n=44 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (ITT Population) n=44 Participants Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	NMJ Targeted (PP Population) NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (PP Population) Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Change From Baseline of Spasticity Related Pain Measured by Visual Analogue Scale (VAS), Assessed by the Subject Week 4	-5.80 Change in VAS from Baseline Standard Deviation 23.07	-4.35 Change in VAS from Baseline Standard Deviation 12.29	—	—
Change From Baseline of Spasticity Related Pain Measured by Visual Analogue Scale (VAS), Assessed by the Subject Week 12	-0.03 Change in VAS from Baseline Standard Deviation 26.02	0.03 Change in VAS from Baseline Standard Deviation 20.67	—	—

SECONDARY outcome

Timeframe: Baseline

Population: ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in the analysis.

Pain assessment using the VAS. The VAS was a 100 mm straight horizontal line scoring scale. Score range on VAS was from 0 to 100 where 0 indicated no pain and 100 indicated worst pain imaginable.

Outcome measures

Outcome measures
Measure	NMJ Targeted (ITT Population) n=36 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (ITT Population) n=37 Participants Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	NMJ Targeted (PP Population) NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (PP Population) Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Injection Site Pain Measured by VAS at Day 1.	25.67 mm Standard Deviation 25.37	30.68 mm Standard Deviation 27.33	—	—

SECONDARY outcome

Timeframe: Up to Week 12

Population: ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in the analysis. Only overall GAS score data are summarised below.

At Baseline, an agreed primary goal related to elbow flexion in one of the following categories was determined: active function, impairment, involuntary movement, mobility, pain passive function or other. Each goal was usually rated -1, unless the subject was as bad as he/she could be in that particular goal area, in which case the Baseline score was -2. The evaluator rated the outcome score at Week 4 or Week 12, depending on the time point defined at the baseline visit (Visit 1), using the GAS five-point scale (-2, -1, 0, +1 and +2).

Outcome measures

Outcome measures
Measure	NMJ Targeted (ITT Population) n=33 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (ITT Population) n=41 Participants Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	NMJ Targeted (PP Population) NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (PP Population) Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Achievement of the Primary Goal Measured by Goal Attainment Scale (GAS) Overall GAS score of +2	1 Participants	1 Participants	—	—
Achievement of the Primary Goal Measured by Goal Attainment Scale (GAS) Overall GAS score of -2	3 Participants	1 Participants	—	—
Achievement of the Primary Goal Measured by Goal Attainment Scale (GAS) Overall GAS score of -1	9 Participants	15 Participants	—	—
Achievement of the Primary Goal Measured by Goal Attainment Scale (GAS) Overall GAS score of 0	11 Participants	18 Participants	—	—
Achievement of the Primary Goal Measured by Goal Attainment Scale (GAS) Overall GAS score of +1	9 Participants	6 Participants	—	—

SECONDARY outcome

Timeframe: Up to Week 24

Population: ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in the analysis. If a subject had more than one evaluation entry, the last one was used.

Comparison of treatment effect between previous (prestudy) and study treatment cycles assessed by the subject at the end of study (Week 12 up to Week 24 (Visit 3 or Visit 4)). Categorised as follows: Much worse / Worse / Same / Better / Much better.

Outcome measures

Outcome measures
Measure	NMJ Targeted (ITT Population) n=40 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (ITT Population) n=40 Participants Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	NMJ Targeted (PP Population) NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (PP Population) Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Subject Global Evaluation of Treatment Effect Much Better	3 Participants	2 Participants	—	—
Subject Global Evaluation of Treatment Effect Better	11 Participants	16 Participants	—	—
Subject Global Evaluation of Treatment Effect No Change From Baseline	18 Participants	20 Participants	—	—
Subject Global Evaluation of Treatment Effect Worse	7 Participants	2 Participants	—	—
Subject Global Evaluation of Treatment Effect Much Worse	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Following last visit of the last subject at each site

Population: The question on preferred injection technique was answered by 3 of the 20 Investigators.

When all patients at the site had completed the study (last subject last visit) a global assessment of the injection technique was to be made by the Investigators. The following question was answered: "Based on your experience during this study, which injection technique do you prefer?"

Outcome measures

Outcome measures
Measure	NMJ Targeted (ITT Population) n=3 Participants NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (ITT Population) Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	NMJ Targeted (PP Population) NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice (PP Population) Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.
Investigator Preference of Injection Technique NMJ Targeted	1 Investigators	—	—	—
Investigator Preference of Injection Technique Current Clinical Practice	2 Investigators	—	—	—

Adverse Events

NMJ Targeted

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Current Clinical Practice

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	NMJ Targeted n=44 participants at risk NMJ targeted technique and low-concentration dilution (Dysport 100 U/mL): A single injection per muscle was given in the midline of the band of NMJ zones. With a Dysport dilution of 100 U/mL the volume to be injected varied between 0.4 mL and 2.0 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment.	Current Clinical Practice n=44 participants at risk Current clinical practice technique and high-concentration dilution (Dysport 300 U/mL): The same number and sites of injections/deposits per muscle were given as per prestudy. With a Dysport dilution of 300 U/mL the volume to be injected varied between 0.1 mL and 0.7 mL per muscle. The dose and the choice of muscles involved in the elbow flexion were the same as for the last prestudy treatment .
Infections and infestations Cystitis	2.3% 1/44 • Adverse events (AEs) were monitored from informed consent to the time when the subject's participation in the study ended (Week 12 to Week 24 (Visit 3 or Visit 4)). AEs were elicited by direct, non-leading questioning at each clinic visit or by spontaneous reports. The safety population was defined as all subjects who received at least one dose of study medication. The safety population was analysed using subjects as treated. If a subject experienced more than one event in a System Organ Class (SOC), the subject was counted only once in that SOC.	0.00% 0/44 • Adverse events (AEs) were monitored from informed consent to the time when the subject's participation in the study ended (Week 12 to Week 24 (Visit 3 or Visit 4)). AEs were elicited by direct, non-leading questioning at each clinic visit or by spontaneous reports. The safety population was defined as all subjects who received at least one dose of study medication. The safety population was analysed using subjects as treated. If a subject experienced more than one event in a System Organ Class (SOC), the subject was counted only once in that SOC.
Infections and infestations Urinary tract infection	0.00% 0/44 • Adverse events (AEs) were monitored from informed consent to the time when the subject's participation in the study ended (Week 12 to Week 24 (Visit 3 or Visit 4)). AEs were elicited by direct, non-leading questioning at each clinic visit or by spontaneous reports. The safety population was defined as all subjects who received at least one dose of study medication. The safety population was analysed using subjects as treated. If a subject experienced more than one event in a System Organ Class (SOC), the subject was counted only once in that SOC.	2.3% 1/44 • Adverse events (AEs) were monitored from informed consent to the time when the subject's participation in the study ended (Week 12 to Week 24 (Visit 3 or Visit 4)). AEs were elicited by direct, non-leading questioning at each clinic visit or by spontaneous reports. The safety population was defined as all subjects who received at least one dose of study medication. The safety population was analysed using subjects as treated. If a subject experienced more than one event in a System Organ Class (SOC), the subject was counted only once in that SOC.
Injury, poisoning and procedural complications Femoral neck fracture	2.3% 1/44 • Adverse events (AEs) were monitored from informed consent to the time when the subject's participation in the study ended (Week 12 to Week 24 (Visit 3 or Visit 4)). AEs were elicited by direct, non-leading questioning at each clinic visit or by spontaneous reports. The safety population was defined as all subjects who received at least one dose of study medication. The safety population was analysed using subjects as treated. If a subject experienced more than one event in a System Organ Class (SOC), the subject was counted only once in that SOC.	0.00% 0/44 • Adverse events (AEs) were monitored from informed consent to the time when the subject's participation in the study ended (Week 12 to Week 24 (Visit 3 or Visit 4)). AEs were elicited by direct, non-leading questioning at each clinic visit or by spontaneous reports. The safety population was defined as all subjects who received at least one dose of study medication. The safety population was analysed using subjects as treated. If a subject experienced more than one event in a System Organ Class (SOC), the subject was counted only once in that SOC.
Nervous system disorders Epilepsy	0.00% 0/44 • Adverse events (AEs) were monitored from informed consent to the time when the subject's participation in the study ended (Week 12 to Week 24 (Visit 3 or Visit 4)). AEs were elicited by direct, non-leading questioning at each clinic visit or by spontaneous reports. The safety population was defined as all subjects who received at least one dose of study medication. The safety population was analysed using subjects as treated. If a subject experienced more than one event in a System Organ Class (SOC), the subject was counted only once in that SOC.	2.3% 1/44 • Adverse events (AEs) were monitored from informed consent to the time when the subject's participation in the study ended (Week 12 to Week 24 (Visit 3 or Visit 4)). AEs were elicited by direct, non-leading questioning at each clinic visit or by spontaneous reports. The safety population was defined as all subjects who received at least one dose of study medication. The safety population was analysed using subjects as treated. If a subject experienced more than one event in a System Organ Class (SOC), the subject was counted only once in that SOC.

Other adverse events

Additional Information

Medical Director, Neurology

Ipsen

Phone: [email protected]

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor required reasonable opportunity to review any abstract, presentation or paper before the material was submitted for publication or communicated. This also applied to any amendments that were requested by referees or journal editors. The Sponsor committed to comment on the draft documents within the time period agreed in the contractual arrangements between the Sponsor and authors or their institution. Delays were also possible if publication would adversely affect patentability.
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