A Phase 3 interventional study of NT 201 and Placebo in Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines), sponsored by Merz North America, Inc.. Completed at 12 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Merz North America, Inc. (part of Merz Pharma) · Phase 3, Interventional, and Treatment
The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face (Upper Facial Lines [UFL]): Horizontal Forehead Lines [HFL], Glabellar Frown Lines [GFL], and Lateral Canthal Lines [LCL]). It is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (MP) followed by an open-label extension (OLEX) period.
Merz North America, Inc. is the lead sponsor of 53 studies on the registry; 2 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 19 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects will receive placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period.
Drug: Placebo
Subjects will receive a total of 64 Units (U) of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period.
Drug: NT 201
Subjects will receive a total of 24 U NT 201: placebo injection both in the GFL and HFL area, and 24 U NT 201 injection in the LCL area (12 U per side) on Day 1 of main period.
Drug: NT 201 · Drug: Placebo
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
Drug: NT 201
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
Drug: NT 201
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
Drug: NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Also known as: IncobotulinumtoxinA, Xeomin, Botulinum toxin type A (150 kiloDalton), free from complexing protein
Solution for injection prepared by reconstitution of powder with percent (%) Sodium Chloride (NaCl).
Main Period: Percentage of Glabellar Frown Line (GFL) Responders at Day 30
The Merz aesthetics scales (MAS) are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. GFL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for GFL at maximum contraction as assessed by both the investigator and the subject. The MAS for GFL ranged as 0 to 4 where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".
Time frame: Day 30
Main Period: Percentage of Horizontal Forehead Lines (HFL) Responders at Day 30
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. HFL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for HFL at maximum contraction as assessed by both the investigator and the subject. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
Time frame: Day 30
Main Period: Percentage of Lateral Canthal Lines (LCL) Responders at Day 30
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. LCL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for both left and right LCL at maximum contraction as assessed by both the investigator and the subject. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
Time frame: Day 30
Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Investigator at Day 30
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. MAS for GFL ranged as 0 to 4, where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".
Time frame: Day 30
Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Investigator at Day 30
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
Time frame: Day 30
Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator at Day 30
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
Time frame: Day 30
Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Subject at Day 30
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for GFL ranged as 0 to 4, where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".
Time frame: Day 30
Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Subject at Day 30
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
Time frame: Day 30
Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Subject at Day 30
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
Time frame: Day 30
Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Subjects
The GAIS is a 7-point Likert scale capturing the global aesthetic improvement ranging from +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the subject. GAIS as assessed by the subject at Day 30 was analyzed using an analysis of covariance (ANCOVA) model.
Time frame: Day 30
Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 of Main Period on MAS for GFL at Maximum Contraction as Assessed by the Investigator
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph- based outcome instruments designed specifically for assessment of each upper facial area. The MAS for GFL ranged as 0 to 4 where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".
Time frame: Day 30
Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 of Main Period on MAS for HFL at Maximum Contraction as Assessed by the Investigator
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
Time frame: Day 30
Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 of Main Period on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
Time frame: Day 30
Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Investigator
The GAIS is a 7-point Likert scale capturing the global aesthetic improvement ranging from +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator. GAIS as assessed by the investigator at Day 30 was analyzed using an ANCOVA model.
Time frame: Day 30
Main Period: Number of Subjects With Related Treatment-Emergent Adverse Events (TEAEs)
TEAEs during the Main Period are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment and before date and time of first administration of study treatment in the OLEX period or the final study visit, if subject was not treated in the OLEX period. An AE is considered to be related if a causal relationship between study treatment and the AE is at least reasonably possible.
Time frame: Up to 22 weeks
OLEX: Number of Subjects With Related TEAEs
TEAEs of the OLEX period are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment in the OLEX period up to and including the final study visit. An AE is considered to be related if a causal relationship between study treatment and the AE is at least reasonably possible.
Time frame: Up to 39 weeks
Subjects were recruited at 12 investigational sites in Germany.
| Milestone | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) | OLEX: NT 201 (Main Period: Group P) | OLEX: NT 201 (Main Period: Group U) | OLEX: NT 201 (Main Period: Group L) |
|---|---|---|---|---|---|---|
| Started | 94 | 184 | 90 | 0 | 0 | 0 |
| Completed | 91 | 180 | 87 | 0 | 0 | 0 |
| Not completed | 3 | 4 | 3 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 2 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 2 | 1 | 0 | 0 | 0 |
| Milestone | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) | OLEX: NT 201 (Main Period: Group P) | OLEX: NT 201 (Main Period: Group U) | OLEX: NT 201 (Main Period: Group L) |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 89 | 170 | 87 |
| Completed | 0 | 0 | 0 | 81 | 156 | 76 |
| Not completed | 0 | 0 | 0 | 8 | 14 | 11 |
| Withdrew: Adverse event | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 3 | 0 | 2 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Other eligibility criteria for re-injection not met | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: No need for re-injection | 0 | 0 | 0 | 1 | 9 | 3 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 5 | 4 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 0 | 2 |
The Merz aesthetics scales (MAS) are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. GFL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for GFL at maximum contraction as assessed by both the investigator and the subject. The MAS for GFL ranged as 0 to 4 where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Percentage of Glabellar Frown Line (GFL) Responders at Day 30 | 0 | 49.5 |
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. HFL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for HFL at maximum contraction as assessed by both the investigator and the subject. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Percentage of Horizontal Forehead Lines (HFL) Responders at Day 30 | 0 | 57.7 |
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. LCL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for both left and right LCL at maximum contraction as assessed by both the investigator and the subject. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Percentage of Lateral Canthal Lines (LCL) Responders at Day 30 | 0 | 32.4 |
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. MAS for GFL ranged as 0 to 4, where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Investigator at Day 30 | 0.0 | 86.8 |
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Investigator at Day 30 | 1.1 | 86.3 |
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator at Day 30 | 2.1 | 75.8 |
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for GFL ranged as 0 to 4, where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Subject at Day 30 | 1.1 | 73.6 |
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Subject at Day 30 | 2.1 | 79.1 |
The MAS are 5-point scales used to identify responders in clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Subject at Day 30 | 3.2 | 65.4 |
The GAIS is a 7-point Likert scale capturing the global aesthetic improvement ranging from +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the subject. GAIS as assessed by the subject at Day 30 was analyzed using an analysis of covariance (ANCOVA) model.
| score on a scale | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) |
|---|---|---|
| Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Subjects | 0.02 (-0.11 to 0.15) | 2.00 (1.90 to 2.09) |
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph- based outcome instruments designed specifically for assessment of each upper facial area. The MAS for GFL ranged as 0 to 4 where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) |
|---|---|---|---|
| Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 of Main Period on MAS for GFL at Maximum Contraction as Assessed by the Investigator | 5.5 | 96.7 | 4.5 |
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) |
|---|---|---|---|
| Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 of Main Period on MAS for HFL at Maximum Contraction as Assessed by the Investigator | 3.3 | 96.1 | 3.4 |
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
| percentage of subjects | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) |
|---|---|---|---|
| Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 of Main Period on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator | 8.8 | 91.7 | 68.2 |
The GAIS is a 7-point Likert scale capturing the global aesthetic improvement ranging from +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse), as assessed by the investigator. GAIS as assessed by the investigator at Day 30 was analyzed using an ANCOVA model.
| score on a scale | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) |
|---|---|---|---|
| Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Investigator | 0.03 (-0.09 to 0.14) | 2.23 (2.14 to 2.31) | 0.68 (0.56 to 0.80) |
TEAEs during the Main Period are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment and before date and time of first administration of study treatment in the OLEX period or the final study visit, if subject was not treated in the OLEX period. An AE is considered to be related if a causal relationship between study treatment and the AE is at least reasonably possible.
| Participants | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 (Group L) |
|---|---|---|---|
| Main Period: Number of Subjects With Related Treatment-Emergent Adverse Events (TEAEs) | 12 | 35 | 10 |
TEAEs of the OLEX period are defined as adverse events (AEs) with onset or worsening on or after date and time of first dose of study treatment in the OLEX period up to and including the final study visit. An AE is considered to be related if a causal relationship between study treatment and the AE is at least reasonably possible.
| Participants | OLEX: NT 201 (Main Period: Group P) | OLEX: NT 201 (Main Period: Group U) | OLEX: NT 201 (Main Period: Group L) |
|---|---|---|---|
| OLEX: Number of Subjects With Related TEAEs | 18 | 32 | 12 |
Collected over Main Period: Up to 22 weeks; OLEX Period: Up to 39 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Main Period: Placebo (Group P) | 0/94 (0%) | 4/94 (4.3%) | 23/94 (24.5%) |
| Main Period: NT 201 (Group U) | 0/184 (0%) | 1/184 (0.5%) | 43/184 (23.4%) |
| Main Period: NT 201 and Placebo (Group L) | 0/90 (0%) | 2/90 (2.2%) | 23/90 (25.6%) |
| OLEX: NT 201 (Main Period: Group P) | 0/89 (0%) | 2/89 (2.2%) | 39/89 (43.8%) |
| OLEX: NT 201 (Main Period: Group U) | 0/170 (0%) | 6/170 (3.5%) | 74/170 (43.5%) |
| OLEX: NT 201 (Main Period: Group L) | 0/87 (0%) | 3/87 (3.4%) | 29/87 (33.3%) |
| Event | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) | OLEX: NT 201 (Main Period: Group P) | OLEX: NT 201 (Main Period: Group U) | OLEX: NT 201 (Main Period: Group L) |
|---|---|---|---|---|---|---|
| Drug hypersensitivityImmune system disorders | 0/94 | 0/184 | 0/90 | 0/89 | 0/170 | 1/87 |
| Haemoglobin decreasedInvestigations | 0/94 | 0/184 | 0/90 | 0/89 | 0/170 | 1/87 |
| Back painMusculoskeletal and connective tissue disorders | 0/94 | 0/184 | 0/90 | 0/89 | 0/170 | 1/87 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/94 | 0/184 | 0/90 | 0/89 | 0/170 | 1/87 |
| VertigoEar and labyrinth disorders | 0/94 | 0/184 | 0/90 | 1/89 | 0/170 | 0/87 |
| GoitreEndocrine disorders | 0/94 | 0/184 | 0/90 | 1/89 | 1/170 | 0/87 |
| Inguinal herniaGastrointestinal disorders | 1/94 | 0/184 | 0/90 | 1/89 | 0/170 | 0/87 |
| SciaticaNervous system disorders | 0/94 | 0/184 | 1/90 | 0/89 | 0/170 | 0/87 |
| Nasal septum deviationRespiratory, thoracic and mediastinal disorders | 0/94 | 0/184 | 1/90 | 0/89 | 0/170 | 0/87 |
| Abdominal painGastrointestinal disorders | 1/94 | 0/184 | 0/90 | 0/89 | 1/170 | 0/87 |
| Event | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) | OLEX: NT 201 (Main Period: Group P) | OLEX: NT 201 (Main Period: Group U) | OLEX: NT 201 (Main Period: Group L) |
|---|---|---|---|---|---|---|
| COVID-19Infections and infestations | 4/94 | 2/184 | 0/90 | 13/89 | 33/170 | 12/87 |
| NasopharyngitisInfections and infestations | 4/94 | 3/184 | 3/90 | 9/89 | 22/170 | 11/87 |
| Injection site haematomaGeneral disorders | 8/94 | 15/184 | 9/90 | 11/89 | 22/170 | 9/87 |
| HeadacheNervous system disorders | 8/94 | 18/184 | 7/90 | 9/89 | 9/170 | 2/87 |
| Immunisation reactionImmune system disorders | 2/94 | 10/184 | 9/90 | 4/89 | 8/170 | 8/87 |
The full analysis set (FAS) included all randomized subjects.
| Age, Continuous(years) | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) | Total |
|---|---|---|---|---|
| Mean | 44.8 ± 9.15 | 46.0 ± 9.92 | 45.9 ± 9.88 | 45.7 ± 9.71 |
| Sex: Female, Male(Participants) | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) | Total |
|---|---|---|---|---|
| Female | 84 | 147 | 72 | 303 |
| Male | 10 | 37 | 18 | 65 |
| Ethnicity (NIH/OMB)(Participants) | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 2 | 5 |
| Not Hispanic or Latino | 93 | 182 | 88 | 363 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Main Period: Placebo (Group P) | Main Period: NT 201 (Group U) | Main Period: NT 201 and Placebo (Group L) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 94 | 182 | 89 | 365 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
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Studies of the drug tested here: incobotulinumtoxinA