Trial Outcomes & Findings for IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia (NCT NCT00407030)
NCT ID: NCT00407030
Last Updated: 2013-07-19
Results Overview
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
233 participants
Primary outcome timeframe
Baseline, week 4
Results posted on
2013-07-19
Participant Flow
Participant milestones
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
incobotulinumtoxinA (Xeomin) (120 Units)
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
|
Placebo
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Main Period - 8 to 20 Weeks
STARTED
|
81
|
78
|
74
|
|
Main Period - 8 to 20 Weeks
COMPLETED
|
76
|
75
|
68
|
|
Main Period - 8 to 20 Weeks
NOT COMPLETED
|
5
|
3
|
6
|
|
Extension Period - up to 68 Weeks
STARTED
|
111
|
103
|
0
|
|
Extension Period - up to 68 Weeks
COMPLETED
|
84
|
74
|
0
|
|
Extension Period - up to 68 Weeks
NOT COMPLETED
|
27
|
29
|
0
|
Reasons for withdrawal
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
incobotulinumtoxinA (Xeomin) (120 Units)
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
|
Placebo
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Main Period - 8 to 20 Weeks
Adverse Event
|
2
|
1
|
0
|
|
Main Period - 8 to 20 Weeks
Lack of Efficacy
|
0
|
0
|
3
|
|
Main Period - 8 to 20 Weeks
Lost to Follow-up
|
1
|
1
|
1
|
|
Main Period - 8 to 20 Weeks
Consent Withdrawn
|
1
|
1
|
1
|
|
Main Period - 8 to 20 Weeks
Withdrawal Criteria Occurred
|
0
|
0
|
1
|
|
Main Period - 8 to 20 Weeks
Patient Decision
|
1
|
0
|
0
|
|
Extension Period - up to 68 Weeks
Withdrawal Criteria Occurred
|
4
|
5
|
0
|
|
Extension Period - up to 68 Weeks
Lack of Efficacy
|
11
|
11
|
0
|
|
Extension Period - up to 68 Weeks
Adverse Event
|
1
|
0
|
0
|
|
Extension Period - up to 68 Weeks
Consent Withdrawn
|
4
|
4
|
0
|
|
Extension Period - up to 68 Weeks
Lost to Follow-up
|
5
|
5
|
0
|
|
Extension Period - up to 68 Weeks
Patient Decision
|
1
|
2
|
0
|
|
Extension Period - up to 68 Weeks
Physician Decision
|
1
|
2
|
0
|
Baseline Characteristics
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
Baseline characteristics by cohort
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
incobotulinumtoxinA (Xeomin) (120 Units)
n=78 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
|
Placebo
n=74 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
53.2 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 4Population: Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
Placebo
n=74 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
Placebo
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Placebo
|
-7.3 points on a scale
Standard Error 2.18
|
1.6 points on a scale
Standard Error 2.28
|
—
|
PRIMARY outcome
Timeframe: Baseline, week 4Population: Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=78 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
Placebo
n=74 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
Placebo
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (120 Units) Versus Placebo
|
-10.8 points on a scale
Standard Error 2.11
|
-3.3 points on a scale
Standard Error 2.20
|
—
|
PRIMARY outcome
Timeframe: Baseline, week 4Population: Intention to treat population: all participants randomized were included in the primary efficacy analysis; missing values were imputed using the worst case strategy, i.e. imputation by baseline value
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
Placebo
n=78 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
Placebo
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Change From Baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total Score at Week 4 After Injection of the Main Period - Xeomin (240 Units) Versus Xeomin (120 Units)
|
-10.5 points on a scale
Standard Error 2.25
|
-9.2 points on a scale
Standard Error 2.27
|
—
|
SECONDARY outcome
Timeframe: Baseline, week 8, final visit (up to 20 weeks after injection of the Main Period)Population: Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
The TWSTRS-Total score is the sum of scores of the three components of the scale: * TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity) * TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain) * TWSTRS-Disability score which ranges from 0 (=no disability) to 30 (=maximum disability). The TWSTRS total score ranges from 0 (=best value) to 85 (=worst value). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
Placebo
n=78 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
Placebo
n=74 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Change From Baseline in the TWSTRS-Total Score
Baseline - Week 8
|
-8.2 points on a scale
Standard Deviation 10.54
|
-6.9 points on a scale
Standard Deviation 11.15
|
0.4 points on a scale
Standard Deviation 7.17
|
|
Change From Baseline in the TWSTRS-Total Score
Baseline - Final Visit
|
-4.6 points on a scale
Standard Deviation 7.52
|
-3.6 points on a scale
Standard Deviation 8.07
|
1.7 points on a scale
Standard Deviation 6.15
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)Population: Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
TWSTRS-Disability score which ranges from 0 (=no disability)to 30 (=maximum disability). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
Placebo
n=78 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
Placebo
n=74 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Change From Baseline in the TWSTRS Disability Subscore
Baseline - Week 4
|
-3.0 points on a scale
Standard Deviation 4.35
|
-3.3 points on a scale
Standard Deviation 4.72
|
0.0 points on a scale
Standard Deviation 3.41
|
|
Change From Baseline in the TWSTRS Disability Subscore
Baseline - Week 8
|
-2.4 points on a scale
Standard Deviation 3.98
|
-2.1 points on a scale
Standard Deviation 4.86
|
0.8 points on a scale
Standard Deviation 3.27
|
|
Change From Baseline in the TWSTRS Disability Subscore
Baseline - Final Visit
|
-1.3 points on a scale
Standard Deviation 3.13
|
-1.4 points on a scale
Standard Deviation 3.82
|
1.0 points on a scale
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)Population: Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
TWSTRS-Severity score which ranges from 0 (=absence of severity) to 35 points (=maximum severity). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
Placebo
n=78 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
Placebo
n=74 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Change From Baseline in the TWSTRS Severity Subscore
Baseline - Week 4
|
-5.5 points on a scale
Standard Deviation 5.99
|
-3.9 points on a scale
Standard Deviation 4.34
|
-1.9 points on a scale
Standard Deviation 3.96
|
|
Change From Baseline in the TWSTRS Severity Subscore
Baseline - Week 8
|
-3.5 points on a scale
Standard Deviation 5.39
|
-3.1 points on a scale
Standard Deviation 4.39
|
-0.9 points on a scale
Standard Deviation 3.57
|
|
Change From Baseline in the TWSTRS Severity Subscore
Baseline - Final Visit
|
-1.9 points on a scale
Standard Deviation 3.83
|
-1.1 points on a scale
Standard Deviation 3.18
|
-0.2 points on a scale
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: Baseline, week 4, week 8, final visit (up to 20 weeks after injection of the Main Period)Population: Intention to treat population with missing values imputed using the worst case strategy, i.e. imputation by baseline value
TWSTRS-Pain score which ranges from 0 (=no pain) to 20 (=maximum pain). The change from baseline was calculated as the score at the corresponding visit minus the baseline score.
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
Placebo
n=78 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
Placebo
n=74 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Change From Baseline in the TWSTRS Pain Subscore
Baseline - Week 4
|
-2.4 points on a scale
Standard Deviation 4.36
|
-2.7 points on a scale
Standard Deviation 4.55
|
-0.3 points on a scale
Standard Deviation 2.97
|
|
Change From Baseline in the TWSTRS Pain Subscore
Baseline - Week 8
|
-2.3 points on a scale
Standard Deviation 4.32
|
-1.8 points on a scale
Standard Deviation 4.15
|
0.6 points on a scale
Standard Deviation 2.82
|
|
Change From Baseline in the TWSTRS Pain Subscore
Baseline - Final Visit
|
-1.3 points on a scale
Standard Deviation 3.40
|
-1.1 points on a scale
Standard Deviation 3.96
|
0.9 points on a scale
Standard Deviation 2.56
|
SECONDARY outcome
Timeframe: Final visit (up to 20 weeks after injection of the Main Period)Population: Intention to treat population with missing values imputed by "no effect"
The PEGR is a descriptive subjective 9-point response scale ranging from "complete abolishment of signs and symptoms" (value=+4) down to "very marked worsening" (value=-4).
Outcome measures
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 Participants
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
Placebo
n=78 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
Placebo
n=74 Participants
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Patient Evaluation of Global Response (PEGR) at Final Visit
|
1.3 points on a scale
Standard Deviation 1.84
|
1.3 points on a scale
Standard Deviation 1.77
|
-0.2 points on a scale
Standard Deviation 1.34
|
Adverse Events
incobotulinumtoxinA (Xeomin) (240 Units)
Serious events: 4 serious events
Other events: 27 other events
Deaths: 0 deaths
incobotulinumtoxinA (Xeomin) (120 Units)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 participants at risk
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
incobotulinumtoxinA (Xeomin) (120 Units)
n=78 participants at risk
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
|
Placebo
n=74 participants at risk
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
1.2%
1/81 • Number of events 1 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/78 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/74 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
1/81 • Number of events 1 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/78 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/74 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/81 • Number of events 1 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/78 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/74 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
|
Infections and infestations
Staphylococcal infection
|
1.2%
1/81 • Number of events 1 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/78 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
0.00%
0/74 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
Other adverse events
| Measure |
incobotulinumtoxinA (Xeomin) (240 Units)
n=81 participants at risk
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins")(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection
|
incobotulinumtoxinA (Xeomin) (120 Units)
n=78 participants at risk
incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kD), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection
|
Placebo
n=74 participants at risk
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
|
|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
18.5%
15/81 • Number of events 17 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
11.5%
9/78 • Number of events 10 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
2.7%
2/74 • Number of events 2 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
|
General disorders
Injection site pain
|
3.7%
3/81 • Number of events 3 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
9.0%
7/78 • Number of events 7 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
5.4%
4/74 • Number of events 5 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.1%
9/81 • Number of events 12 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
6.4%
5/78 • Number of events 5 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
1.4%
1/74 • Number of events 1 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
|
Musculoskeletal and connective tissue disorders
Musculosceletal pain
|
3.7%
3/81 • Number of events 4 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
7.7%
6/78 • Number of events 8 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
1.4%
1/74 • Number of events 1 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/81 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
3.8%
3/78 • Number of events 3 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
6.8%
5/74 • Number of events 5 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.8%
12/81 • Number of events 13 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
5.1%
4/78 • Number of events 7 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
4.1%
3/74 • Number of events 3 • All SAEs/AEs during Double-Blind Period after Injection, i.e. up to 8-20 weeks after Main Period injection.
The table of "Other Adverse Events" includes all non-serious AEs. Only results and AEs of the Double-Blind Period are given as the Extension Period was not placebo-controlled. The investigator asked the patient for AEs systematically at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No results to be published without written agreement by sponsor; manuscripts to be sent to sponsor at least 6 weeks before submission. Sponsor to give written opinion within 30 days. Sponsor is entitled to exert influence on the contents of publications, to postpone publications up to 36 months after end of the study, and to name co-authors. In case of justified doubts of sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER