Trial Outcomes & Findings for Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines (NCT NCT03806933)
NCT ID: NCT03806933
Last Updated: 2023-11-15
Results Overview
Duration of effect: time between treatment and first occurrence of relapse to baseline status. If no effect was observed, duration of effect was set to 0. Effect: any improvement (at least 1 point) at maximum frown as assessed by investigator on FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95 percent (%) confidence interval (CI) were calculated using log-log transformation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
241 participants
Primary outcome timeframe
From the time of first treatment up to Day 360
Results posted on
2023-11-15
Participant Flow
Study was conducted at 9 sites in Germany and the United States from 23 January 2019 to 8 October 2020. Out of 256 participants, 15 participants were screen failures and 241 participants were enrolled and randomized in the study. Study had 2 periods: Main Period (MP) and an optional Open-label Extension (OLEX) Period. As planned, combined safety data for MP and OLEX Period was reported.
In MP, Stage 1, participants received NT 201: 20 unit (U), 50 U or 75 U. Based on safety data of Stage 1, Stage 2 was started, and participants received NT 201 20 U or 100 U. After completion of MP, participants had the opportunity to receive an optional follow-up treatment with NT 201 20 U in OLEX period. As planned, 20 U group data from Stages 1 and 2 were pooled.
Participant milestones
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 milliliter (mL) injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Main Period
STARTED
|
61
|
60
|
61
|
59
|
|
Main Period
Safety Evaluation Set (SES)
|
62
|
60
|
61
|
58
|
|
Main Period
COMPLETED
|
57
|
57
|
59
|
56
|
|
Main Period
NOT COMPLETED
|
4
|
3
|
2
|
3
|
|
OLEX Period
STARTED
|
52
|
53
|
56
|
50
|
|
OLEX Period
COMPLETED
|
52
|
53
|
56
|
49
|
|
OLEX Period
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 milliliter (mL) injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Main Period
Physician Decision
|
0
|
0
|
0
|
1
|
|
Main Period
Pregnancy
|
0
|
0
|
1
|
0
|
|
Main Period
Withdrawal by Subject
|
2
|
1
|
1
|
2
|
|
Main Period
Lost to Follow-up
|
2
|
2
|
0
|
0
|
|
OLEX Period
Due to coronavirus disease (COVID) 19 pandemic
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines
Baseline characteristics by cohort
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=61 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=59 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 10.27 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 13.75 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 11.19 • n=4 Participants
|
49.4 years
STANDARD_DEVIATION 11.81 • n=21 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
208 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
213 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Facial Wrinkle Scale (FWS) severity at maximum frown as assessed by the investigator
Moderate
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Facial Wrinkle Scale (FWS) severity at maximum frown as assessed by the investigator
Severe
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
207 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From the time of first treatment up to Day 360Population: The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.
Duration of effect: time between treatment and first occurrence of relapse to baseline status. If no effect was observed, duration of effect was set to 0. Effect: any improvement (at least 1 point) at maximum frown as assessed by investigator on FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95 percent (%) confidence interval (CI) were calculated using log-log transformation.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=61 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=59 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS
|
175 days
Interval 142.0 to 185.0
|
185 days
Interval 182.0 to 205.0
|
210 days
Interval 182.0 to 217.0
|
215 days
Interval 183.0 to 237.0
|
PRIMARY outcome
Timeframe: From the time of first treatment up to Day 390Population: The SES was the subset of all participants who were exposed to study medication.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=62 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=58 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
|
25 Participants
|
23 Participants
|
26 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: From the time of first treatment up to Day 390Population: The SES was the subset of all participants who were exposed to study medication.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=62 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=58 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From the time of first treatment up to Day 390Population: The SES was the subset of all participants who were exposed to study medication.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=62 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=58 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Treatment-emergent Adverse Event of Special Interest (TEAESI)
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From the time of first treatment up to Day 390Population: The SES was the subset of all participants who were exposed to study medication.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=62 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=58 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Treatment Related TEAE
|
7 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: From the time of first treatment up to Day 390Population: The SES was the subset of all participants who were exposed to study medication.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=62 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=58 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Number of Participants With at Least One Treatment Related TESAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the time of first treatment up to Day 360Population: The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.
Duration of effect was defined as time between treatment and first point in time when score was moderate or severe again. If no effect was observed, duration of effect was set to 0. Effect was defined by a score of none (0) or mild (1) at maximum frown as assessed by investigator according to FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=61 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=59 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Duration of Effect Whereby Effect Was Defined as Score of None (0) or Mild (1) at Maximum Frown as Assessed by the Investigator According to FWS
|
113 days
Interval 91.0 to 134.0
|
121 days
Interval 113.0 to 149.0
|
129 days
Interval 122.0 to 157.0
|
148 days
Interval 125.0 to 173.0
|
SECONDARY outcome
Timeframe: From the time of first treatment up to Day 360Population: The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.
Duration of effect: time between treatment and first point in time when improvement was less than 2 points again. If no effect was observed, duration of effect was set to 0. Effect: at least a 2-point improvement from baseline at maximum frown as assessed by investigator on the FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95% CI were calculated using log-log transformation.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=61 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=59 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Duration of Effect Whereby Effect Was Defined by 2-point Improvement From Baseline at Maximum Frown as Assessed by the Investigator According to FWS
|
96 days
Interval 90.0 to 118.0
|
118 days
Interval 91.0 to 127.0
|
122 days
Interval 119.0 to 127.0
|
145 days
Interval 120.0 to 149.0
|
SECONDARY outcome
Timeframe: At Day 180Population: The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.
Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). 95% CIs for percentage of participants were based on Pearson-clopper method.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=61 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=59 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS
|
8.2 percentage of participants
Interval 2.7 to 18.1
|
8.3 percentage of participants
Interval 2.8 to 18.4
|
16.4 percentage of participants
Interval 8.2 to 28.1
|
18.6 percentage of participants
Interval 9.7 to 30.9
|
SECONDARY outcome
Timeframe: At Day 180Population: The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.
Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=61 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=59 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS
|
6.6 percentage of participants
Interval 1.8 to 15.9
|
10.0 percentage of participants
Interval 3.8 to 20.5
|
19.7 percentage of participants
Interval 10.6 to 31.8
|
16.9 percentage of participants
Interval 8.4 to 29.0
|
SECONDARY outcome
Timeframe: At Day 180Population: The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.
Investigator's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=61 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=59 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Investigator's Rating on FWS
|
32.8 percentage of participants
Interval 21.3 to 46.0
|
43.3 percentage of participants
Interval 30.6 to 56.8
|
52.5 percentage of participants
Interval 39.3 to 65.4
|
52.5 percentage of participants
Interval 39.1 to 65.7
|
SECONDARY outcome
Timeframe: At Day 180Population: The FAS was subset of participants exposed to study medication for whom any efficacy variable was available.
Participant's FWS assessed status of GFL according to the 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for participant's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). 95% CI for percentage of participants were based on Pearson-clopper method.
Outcome measures
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=61 Participants
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 Participants
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 Participants
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=59 Participants
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Participant's Rating on FWS
|
37.7 percentage of participants
Interval 25.6 to 51.0
|
36.7 percentage of participants
Interval 24.6 to 50.1
|
52.5 percentage of participants
Interval 39.3 to 65.4
|
45.8 percentage of participants
Interval 32.7 to 59.2
|
Adverse Events
Stage 1 and 2 Pooled: NT 201 20 U
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
NT 201 50 U
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
NT 201 75 U
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
NT 201 100 U
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=62 participants at risk
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 participants at risk
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 participants at risk
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=58 participants at risk
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/62 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
0.00%
0/60 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
0.00%
0/61 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
1.7%
1/58 • Number of events 1 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
Other adverse events
| Measure |
Stage 1 and 2 Pooled: NT 201 20 U
n=62 participants at risk
Participants from Stages 1 and 2 received NT 201 20 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. This arm consisted of pooled data of all participants who received NT 201 20 U in Stages 1 and 2 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 50 U
n=60 participants at risk
Participants from Stage 1 received NT 201 50 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 75 U
n=61 participants at risk
Participants from Stage 1 received NT 201 75 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
NT 201 100 U
n=58 participants at risk
Participants from Stage 2 received NT 201 100 U, powder for solution for injection, intramuscularly with the total amount of 0.25 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.05 mL per injection site) on Day 1 of MP. Participants had the opportunity to receive an optional follow-up treatment with the dose of NT 201 20 U with the total amount of 0.5 mL injected into the glabellar area in equal aliquots administered to 5 injection sites (0.1 mL per injection site) in the OLEX period.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
9.7%
6/62 • Number of events 8 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
10.0%
6/60 • Number of events 8 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
1.6%
1/61 • Number of events 1 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
6.9%
4/58 • Number of events 4 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
|
Infections and infestations
Nasopharyngitis
|
17.7%
11/62 • Number of events 14 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
10.0%
6/60 • Number of events 7 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
18.0%
11/61 • Number of events 11 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
13.8%
8/58 • Number of events 9 • From the time of first treatment up to Day 390
As planned, combined safety data for NT 201 administered in MP and OLEX were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the 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