| Primary | Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments. | The primary endpoint is the percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The population used consists of all randomized subjects, who received at least one injection with study medication. Participants were analyzed as randomized. Participants with missing investigator or subject in-clinic assessments with the Facial Wrinkle Scale (FWS) at baseline or week 4 were assigned as being non-responders. | Posted | | Count of Participants | | Participants | | Week 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1mL i.m. injections into glabellar area |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Cochran-Mantel-Haenszel | | <0.001 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Percentage of Responders at Maximum Frown at Week 12 | Percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 12 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The population used consists of all randomized subjects, who received at least one injection with study medication. Participants were analyzed as randomized. Participants with missing investigator or subject in-clinic assessments with the Facial Wrinkle Scale (FWS) at baseline or week 12 were assigned as being non-responders. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1mL i.m. injections into glabellar area |
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| Secondary | Percentage of Responders at Week 16 | Percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 16 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available for week 16 or who were re-treated before week 16. They were analyzed as randomized and participants who were re-treated before week 16 were counted as non-responders. | Posted | | Count of Participants | | Participants | | Week 16 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1 mL i.m. injections into glabellar area |
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| Secondary | The Percentage of Subjects With a ≥ 1 Point Reduction in Facial Wrinkle Scale (FWS) Score at Rest at Week 4 Based Separately on the Investigators´ and the Subjects´ In-clinic Assessments | The percentage of subjects with a ≥ 1 point reduction in Facial Wrinkle Scale (FWS) score at rest at week 4 in the first treatment cycle, based separately on the investigators' and the subjects' in-clinic assessments (applicable only for subjects who have a FWS score at rest ≥ 1 at baseline). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The population used consists of all randomized subjects who received at least one injection with study medication and who had a Facial Wrinkle Scale (FWS) score at rest >=1 at baseline. Participants were analyzed as randomized. Participants with missing investigator or subject in-clinic assessments with the Facial Wrinkle Scale at week 4 were assigned as being non-responders. | Posted | | Count of Participants | | Participants | | Week 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | |
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| Secondary | Percentage of Responders at Week 20 or Later (After the First Treatment). | Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement ≥2 points in FWS score (at maximum frown) at the week 20 visit (or later) relative to baseline, based on both the investigator's and the subject's in-clinic assessment percentage of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at week 20 visit or later in the first treatment cycle), relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The week 20 analysis population includes all randomized subjects who received at least one injection with study medication and have data available or were re-treated before week 20, with re-treated participants counted as non-responders. Post-week 20 analysis includes all randomized subjects with at least one injection with study medication, available data for the respective visit, and no re-treatment before that visit. | Posted | | Count of Participants | | Participants | | Week 20, 24, 28, 32 of Treatment Cycle 1 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. |
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| Secondary | Extent of Change in Psychological Impact | Extent of change in psychological impact at week 4 after first treatment, relative to baseline, assessed by modified Skindex-16 (Glabellar Line Quality of Life Scale, [GL-QoL]): Each of 7 items rated on 5-point scale: 0/Never, 1/Rarely, 2/Sometimes, 3/Often, 4/Always bothered, than rescaled to a 0 to 100 standardized score; Emotional Domain is the mean of 4 of the items; Social Functioning Domain is the mean of 3 of the items; Overall score is the mean of all 7 items. All reported scores ranging from 0 (best outcome) to 100 (worst outcome). validated FACE-Q Appraisal of Lines Between Eyebrows scale: Each of 7 items rated on 4-point scale: 1/Not at all, 2/a little, 3/moderately, 4/extremely. Reported score is the sum of the 7 items, standardized on a scale from 0 (worst outcome) to 100 (best outcome). Age Appraisal visual analog scale [VAS]: Perception of Age compared to actual age, in years ranging from -15 years (best outcome) to +15 years (worst outcome). | The population used consists of all randomized subjects, who received at least one injection with study medication and who have data available for week 4. Participants were analyzed as randomized. | Posted | | Mean | Standard Deviation | units on a scale | | Week 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | |
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| Secondary | Responder Rate at Weeks 1, 2 and 8 | The percentage of responders among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score at maximum frown of 0 or 1 and an improvement ≥ 2 points in FWS score (at maximum frown) during the first treatment cycle visit relative to baseline, based on both the investigators' and the subjects' in-clinic assessments (composite endpoint, at weeks 1, 2 and 8). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The population used consists of all randomized subjects, who received at least one injection with study medication (independent of whether it is BoNT/A-DP or placebo). Participants were analyzed as randomized. Participants with missing investigator or subject in-clinic assessments with the Facial Wrinkle Scale (FWS) at baseline or the respective visit were assigned as being non-responders. | Posted | | Count of Participants | | Participants | | Week 1, Week 2, and Week 8 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1 mL i.m. injections into glabellar area |
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| Secondary | The Percentage of Subjects With ≥ 2-point Reduction in Facial Wrinkle Scale (FWS) Score (at Maximum Frown) | The percentage of subjects with ≥ 2-point reduction in Facial Wrinkle Scale (FWS) score (at maximum frown) in the BoNT/A-DP and placebo groups during the first treatment cycle visit relative to baseline, based on the independent rater's assessment of photographs (at baseline and visits 2, 4, 12, 16 and 20 weeks after treatment, within the first treatment cycle). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The population used consists of all randomized subjects, who received at least one injection with study medication and for whom independent rater's assessments of photographs are available for the respective timepoint. Participants were analyzed as randomized. The median of all assessments for the same photograph were taken into account. | Posted | | Count of Participants | | Participants | | Week 2, 4, 12, 16 and 20 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1 mL i.m. injections into glabellar area |
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| Secondary | Time to Onset of Effect in the BoNT/A-DP and Placebo Groups in the First Treatment Cycle | Time to onset of effect in the BoNT/A-DP and placebo groups in the first treatment cycle, as measured at weeks 1, 2 and 4 based separately on subject and investigator assessment. Onset of effect defined as at least a 1 point improvement in Facial Wrinkle Scale (FWS) score from baseline (at maximum frown). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The population used consists of all randomized subjects who received at least one injection with study drug. Participants were analyzed as randomized. | Posted | | Median | Inter-Quartile Range | Days | | From treatment at Day 0 to Week 4 in Treatment Cycle 1 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1 mL i.m. injections into glabellar area |
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| Secondary | Satisfaction With Treatment, During Each Treatment Cycle, as Assessed by the Validated FACE-Q Satisfaction With Outcome Scale. | The extent of subject perceptions of effect of, and satisfaction with, treatment in the BoNT/A-DP and placebo groups, at week 4 of each treatment cycle, as assessed by the validated FACE-Q Satisfaction with Outcome Scale. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: "definitely agree," "somewhat agree," "somewhat disagree," and "definitely disagree." | The population used consists of all randomized subjects, who received at least one injection with study medication in the respective treatment cycle. Participants were analyzed as randomized. | Posted | | Count of Participants | | Participants | | Week 4 of Treatment Cycles 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1 mL i.m. injections into glabellar area |
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| Secondary | The Percentage of Subjects With a ≥ 1 Point Reduction in Facial Wrinkle Scale (FWS) Score at Rest Based on the Independent Rater's Assessment of Photos. | The percentage of subjects with a ≥ 1 point reduction in Facial Wrinkle Scale (FWS) score at rest in the BoNT/A-DP and placebo groups, relative to baseline, during the first treatment cycle, based on the independent rater's assessment of photos. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The population used consists of all randomized subjects, who received at least one injection with study medication and for whom independent rater's assessments of photographs were performed. Participants were analyzed as randomized. The median of all assessments for the same photograph were taken into account. | Posted | | Count of Participants | | Participants | | Week 2, 4, 12, 16, 20, 24 and 28 of Treatment Cycle 1 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1 mL i.m. injections into glabellar area |
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| Secondary | Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at 4 Weeks After Re-treatment Relative to the Rating at the Preceding End-of-Cycle Visit. | The percentage of subjects with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 2 points in FWS score (at maximum frown) at 4 weeks after re-treatment relative to the rating at the preceding end-of-cycle visit, based on both the investigator's and the subject's in-clinic assessments (composite endpoint). FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. | The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available for the respective timepoint. Participants were analyzed as randomized | Posted | | Count of Participants | | Participants | | Week 4 of Treatment Cycles 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A Open Label Extension Arm | Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to 3 treatment cycles. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area in up to 3 treatment cycles |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) Events of Special Interest (AESIs) | Frequency, severity and causal relationship of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) during the entire study period. | The population used consists of all randomized subjects, who received at least one injection with study medication. Participants were analyzed as treated. | Posted | | Count of Participants | | Participants | | Through study completion (60 weeks) | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1 mL i.m. injections into glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm | |
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| Secondary | Number of Participants With Neutralizing Anti-Drug Antibodies | Number of Participants with Neutralizing Anti-Drug Antibodies Antibody formation, evaluation pre-dose before each treatment, at 4 weeks after each treatment and at the final study visit | The population used consists of all subjects who received at least one injection with study medication. Participants were analyzed as treated. Confirmation assays have only been performed for subjects with a reactive Screening Assay result. | Posted | | Count of Participants | | Participants | | Through study completion (60 weeks) | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. | | OG001 | Placebo | Placebo will be administered in double blind fashion in cycle 1. divided in five 0.1 mL i.m. injections into the glabellar area. Placebo: Injection, 0.9% sodium chloride divided in five 0.1mL i.m. injections into glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm | |
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| Secondary | Change From Baseline of Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase | Safety assessments by evaluating change from baseline of Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | U/L | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 | |
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| Secondary | Change From Baseline of Bilirubin and Creatinine | Safety assessments by evaluating change from baseline of Bilirubin and Creatinine as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | μmol/L | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 | Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to three additional treatment cycles. This arm is designated for Study Treatment Cycle 2. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area in Treatment Cycle 2 |
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| Secondary | Change From Baseline of Blood Urea Nitrogen, Cholesterol, Glucose, Potassium, Sodium | Safety assessments by evaluating change from baseline of Blood Urea Nitrogen, Cholesterol, Glucose, Potassium, Sodium as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | mmol/L | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 | Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to three additional treatment cycles. This arm is designated for Study Treatment Cycle 2. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area in Treatment Cycle 2 |
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| Secondary | Change From Baseline of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets | Safety assessments by evaluating change from baseline of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | (x10^9 cells/L) | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 | |
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| Secondary | Change From Baseline of Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocytes | Safety assessments by evaluating change from baseline of Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes, Neutrophils/Leukocyte as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | % of leukocytes | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 |
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| Secondary | Change From Baseline of Erythrocytes | Safety assessments by evaluating change from baseline of Erythrocytes as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | (x10^12 cells/L) | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 | Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to three additional treatment cycles. This arm is designated for Study Treatment Cycle 2. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area in Treatment Cycle 2 |
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| Secondary | Change From Baseline of Erythrocytes MCHC, Hemoglobin | Safety assessments by evaluating change from baseline of Erythrocytes MCHC, Hemoglobin as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | g/dL | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 | Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to three additional treatment cycles. This arm is designated for Study Treatment Cycle 2. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area in Treatment Cycle 2 |
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| Secondary | Change From Baseline of Erythrocyte MCV | Safety assessments by evaluating change from baseline of Erythrocyte MCV as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | fL | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 | Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to three additional treatment cycles. This arm is designated for Study Treatment Cycle 2. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area in Treatment Cycle 2 |
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| Secondary | Change From Baseline of Systolic and Diastolic Blood Pressure | Safety assessments by evaluating change from baseline of Systolic and Diastolic Blood Pressure as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | mmHg | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 | Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to three additional treatment cycles. This arm is designated for Study Treatment Cycle 2. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area in Treatment Cycle 2 |
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| Secondary | Change From Baseline of Pulse Rate | Safety assessments by evaluating change from baseline of Pulse Rate as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and have data available for the respective visit. Participants were analyzed as treated. | Posted | | Mean | Standard Deviation | bpm | | Week 4 after treatment in treatment cycle 1, 2, 3 and 4 | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area | | OG001 | Placebo | Placebo will be administered in double blind fashion in Treatment Cycle 1 divided in five 0.1 mL injections into the glabellar area. Placebo: injection, 0.9% sodium chloride divided in five 0.1 mL i.m injections into the glabellar area | | OG002 | Botulinum Toxin A Open Label Extension Arm - Treatment Cycle 2 | Open Label Extension Arm where all Subjects from Arm 1 and 2 can receive Experimental Treatment in up to three additional treatment cycles. This arm is designated for Study Treatment Cycle 2. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area in Treatment Cycle 2 |
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| Secondary | Number of Participants With Normal and Abnormal Electrocardiogram | Safety assessments by evaluating Electrocardiogram as per the study schedule | The population used consists of all subjects who received at least one injection with study medication and who have data available post baseline and the respective category of baseline electrocardiogram interpretation. Participants were analyzed as treated. | Posted | | Count of Participants | | Participants | | Last visit of Treatment Cycle 1 (End of Cycle procedures) conducted upon confirmation of eligibility for retreatment, which was assessed starting 12 weeks post-treatment with 4-weekly evaluations up to a maximum of 48 weeks post treatment. | | | | ID | Title | Description |
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| OG000 | Botulinum Toxin A - Normal Baseline Electrocardiogram Interpretation | Botulinum Toxin A (Clostridium botulinum toxin type A) will be administered in double blind fashion in cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area. Subjects had an electrocardiogram interpretation of normal at baseline. | | OG001 | Botulinum Toxin A - Abnormal Baseline Electrocardiogram Interpretation | Botulinum Toxin A will be administered in double blind fashion in Treatment Cycle 1. 20 Units will be administered (divided in five 0.1 mL i.m injections) into glabellar area. Botulinum Toxin A: Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area Subjects had an electrocardiogram interpretation of abnormal at baseline. |
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