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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002321-34 | EudraCT Number |
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The purpose of this study was to demonstrate the safety and the efficacy of a single treatment of an injectable liquid form of Clostridium botulinum toxin type A haemagglutinin complex (BTX-A-HAC; hereafter referred to as BTX-A-HAC Next Generation (BTX-A-HAC NG)), used for the improvement in the appearance of moderate to severe glabellar lines (the lines between the eyebrows).
At the Baseline Visit (Day 1), subjects were randomised in a ratio of 2:1 to receive either BTX-A-HAC NG solution (50 U) or placebo. Randomisation was stratified according to gender and severity of glabellar lines at maximum frown (moderate to severe) at Baseline. A single dose of BTX-A-HAC NG solution 50 U or placebo was injected on Day 1. Subjects were then monitored at the study centre for 30 minutes. On Day 4, subjects were contacted by telephone for adverse event monitoring and to record concomitant medications and treatments.
Subjects attended follow-up visits at the study centre on Days 8, 15, 29, 57, 85, 113, 148 and 183. The Day 183 follow-up visit was the end of study visit; all subjects who had completed the Day 183 Visit were considered to have completed the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTX-A-HAC NG | Experimental | Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 Unit (U) solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected. |
|
| Placebo | Placebo Comparator | Single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | A solution containing 50 U in 0.25 mL (200 U/mL). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL, containing 50 U of BTX-A-HAC NG (i.e. 10 U/0.05 mL) was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle). |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown on Day 29 and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Study Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nouvelle Clinique Bel Air | Bordeaux | 33200 | France | |||
| Cabinet Medical |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36206385 | Derived | Hilton S, Kestemont P, Sattler G, Volteau M, Thompson C, Andriopoulos B, Prygova I, Berg AK, Ascher B. Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment. Dermatol Surg. 2022 Nov 1;48(11):1198-1202. doi: 10.1097/DSS.0000000000003594. Epub 2022 Oct 7. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
Overall, 190 subjects were screened, five of whom were screening failures. A total of 185 subjects were randomised to receive treatment. One of the subjects who was randomised to placebo did not receive study treatment due to violation of inclusion criterion 3.
Subjects were recruited from nine active sites in France and Germany from January 2015. The study was completed in August 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | BTX-A-HAC NG Solution (50 U) | Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Placebo | Drug | A solution containing only the excipients of BTX-A-HAC NG (identical in appearance to the active product). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle). |
|
| Day 8, 15, 57, 85, 113, 148 and 183 |
| The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). Subjects who were not responders at Day 29 were excluded from the analysis. The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | Day 57, 85, 113, 148 and 183 |
| The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at rest was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at rest at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | Day 8, 15, 29, 57, 85, 113, 148 and 183 |
| The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. Adjusted proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at each post-treatment visit compared with Baseline. The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | Day 8, 15, 29, 57, 85, 113, 148 and 183 |
| The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown. | SSA 4-point photographic scale: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3. A responder at maximum frown was defined as having a severity grade of no wrinkles (Grade 0) or mild wrinkles (Grade 1) at maximum frown at a given visit and a severity grade of moderate wrinkles (Grade 2) or severe wrinkles (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | Day 8, 15, 29, 57, 85, 113, 148 and 183 |
| The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines. | Adjusted proportion of responders at each post-treatment visit (measured by the subject's level of satisfaction with the appearance of their glabellar lines). 4-point categorical scale: Grade 0 - very satisfied; Grade 1 - satisfied; Grade 2 - dissatisfied; Grade 3 - very dissatisfied. A responder was defined as having a satisfaction rating of very satisfied (Grade 0) or satisfied (Grade 1) at a given visit and a satisfaction rating of dissatisfied (Grade 2) or very dissatisfied (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | Day 8, 15, 29, 57, 85, 113, 148 and 183 |
| The Time to Onset of Treatment Response Based on the Subject's Diary Card. | Median time to onset of treatment response: subjects asked to record their assessment of study treatment response in a diary card on Days 1 to 7. They responded 'yes' or 'no' to the following question: 'since being injected have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows)?' | Day 1 to 7 |
| Cannes |
| 06400 |
| France |
| Mediti | Juan-les-Pins | 06160 | France |
| Clinique IENA | Paris | 75116 | France |
| Rzany & Hund Privatpraxis für Dermatologie | Berlin | 10707 | Germany |
| Medical Skin Center | Düsseldorf | 40212 | Germany |
| University of Hamburg | Hamburg | 20146 | Germany |
| Rote Kreuz Krankenhaus | Kassel | 34121 | Germany |
| Hautzentrum am Starnberger See | Starnberg | 82319 | Germany |
| Placebo |
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. |
| COMPLETED |
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| NOT COMPLETED |
|
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Randomised population.
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| ID | Title | Description |
|---|---|---|
| BG000 | BTX-A-HAC NG Solution (50 U) | Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected. |
| BG001 | Placebo | Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown on Day 29 and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | Modified intent-to-treat (mITT) population included all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. Subjects who did not have available data at Day 29 were excluded from the analysis. | Posted | Number | 95% Confidence Interval | Adjusted percentage of responders | Day 29 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo. | Posted | Number | 95% Confidence Interval | Adjusted percentage of responders | Day 8, 15, 57, 85, 113, 148 and 183 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). Subjects who were not responders at Day 29 were excluded from the analysis. The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo. | Posted | Number | 95% Confidence Interval | Adjusted percentage of responders | Day 57, 85, 113, 148 and 183 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. A responder at rest was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at rest at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit.; P=placebo. | Posted | Number | 95% Confidence Interval | Adjusted percentage of responders | Day 8, 15, 29, 57, 85, 113, 148 and 183 |
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| Secondary | The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown. | ILA 4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3. Adjusted proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at each post-treatment visit compared with Baseline. The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo. | Posted | Number | 95% Confidence Interval | Adjusted percentage of responders | Day 8, 15, 29, 57, 85, 113, 148 and 183 |
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| Secondary | The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown. | SSA 4-point photographic scale: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3. A responder at maximum frown was defined as having a severity grade of no wrinkles (Grade 0) or mild wrinkles (Grade 1) at maximum frown at a given visit and a severity grade of moderate wrinkles (Grade 2) or severe wrinkles (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo. | Posted | Number | 95% Confidence Interval | Adjusted percentage of responders | Day 8, 15, 29, 57, 85, 113, 148 and 183 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines. | Adjusted proportion of responders at each post-treatment visit (measured by the subject's level of satisfaction with the appearance of their glabellar lines). 4-point categorical scale: Grade 0 - very satisfied; Grade 1 - satisfied; Grade 2 - dissatisfied; Grade 3 - very dissatisfied. A responder was defined as having a satisfaction rating of very satisfied (Grade 0) or satisfied (Grade 1) at a given visit and a satisfaction rating of dissatisfied (Grade 2) or very dissatisfied (Grade 3) at Baseline (Day 1). The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model. | mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo. | Posted | Number | 95% Confidence Interval | Adjusted percentage of responders | Day 8, 15, 29, 57, 85, 113, 148 and 183 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Time to Onset of Treatment Response Based on the Subject's Diary Card. | Median time to onset of treatment response: subjects asked to record their assessment of study treatment response in a diary card on Days 1 to 7. They responded 'yes' or 'no' to the following question: 'since being injected have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows)?' | mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. One subject from the placebo group was excluded from the analysis due to missing data. | Posted | Median | 95% Confidence Interval | Days | Day 1 to 7 |
|
Screening until end of study (Day 183)/early withdrawal
Adverse events were elicited by direct, nonleading questioning or by spontaneous reports. An adverse event was defined as the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BTX-A-HAC NG Solution (50 U) | Clostridium Botulinum Toxin Type A (BTX-A-HAC NG) 50 U solution, single dose (intramuscular injection). The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. A total of 50 U was injected. | 2 | 125 | 49 | 125 | ||
| EG001 | Placebo | Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. | 1 | 59 | 17 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mydriasis | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Brow ptosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Blepharochalasis | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritis generalised | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Tendon calcification | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
Median could not be calculated because insufficient number of participants with events in the placebo group (3 events for ILA and 8 for SSA).
A plan for scientific publication and presentation of the results could be agreed and implemented by the study investigators or a steering committee. The sponsor required that reasonable opportunity be given to review the content and conclusions of any abstract, presentation, or paper before the material was submitted for publication or communicated. This condition also applied to any amendments that were subsequently requested by referees or journal editors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Neurology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Black/African American |
|
| Other |
|
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| Placebo |
Placebo single dose (intramuscular injection). The total placebo volume (0.25 mL) was divided into five injections (0.05 mL per injection) injected in five predefined sites across the glabellar region. |
|
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| Units | Counts |
|---|---|
| Participants |
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