Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024579-23 | EudraCT Number |
Not provided
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Not provided
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The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin) 400 Units | Experimental | IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. |
|
| Placebo Comparator Arm | Placebo Comparator | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA (400 Units) | Drug | Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4 | The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | Baseline and Week 4 |
| Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12 | A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS) | Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigational Site #001184 | Downey | California | 90242 | United States | ||
| Merz Investigational Site #001208 |
A total of 290 subjects were enrolled in study. One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication. A total of 289 subjects were enrolled in main period. All of the 269 subjects who completed the main period of the study entered the open-label extension period.
A total of 331 individuals suffering from post-stroke lower-limb spasticity were screened and 290 were included in study at 51 sites. One ineligible subject was randomized to placebo but withdrawn from study prior to first treatment with study medication. For purpose of study analysis overall number of subjects enrolled is therefore considered 289.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IncobotulinumtoxinA (Xeomin) 400 Units | IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl), 400 units, total volume 8.0 milliliter (mL); Mode of administration: intramuscular injection. IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection sessions of solution, prepared by reconstitution of powder with 0.9% NaCl, 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Comparator | Drug | Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection |
|
| Week 4, 8, and 12 |
| Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits | The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Here, 'n' specifies those subjects who were evaluated for this outcome measure at given time point. | Baseline, Week 4, 8, and 12 |
| Long Beach |
| California |
| 90806 |
| United States |
| Merz Investigational Site #001244 | Fairfield | Connecticut | 06824 | United States |
| Investigational site #001188 | Doral | Florida | 33172 | United States |
| Merz Investigational Site # 001110 | Overland Park | Kansas | 66211 | United States |
| Merz Investigational Site #001209 | Columbia | Missouri | 65212 | United States |
| Merz Investigational Site #001210 | St Louis | Missouri | 63110 | United States |
| Merz Investigational Site #001198 | Stratford | New Jersey | 08084 | United States |
| Merz Investigational Site #001207 | Plainview | New York | 11803 | United States |
| Merz Investigational Site #001009 | Winston-Salem | North Carolina | 27157 | United States |
| Merz Investigational Site #001206 | Nashville | Tennessee | 37232 | United States |
| Merz Investigational Site #001183 | Houston | Texas | 77030 | United States |
| Merz Investigational Site #001204 | Halifax | Nova Scotia | B3H 4K4 | Canada |
| Merz Investigational Site #001202 | Winnipeg | MB R3A 1M4 | Canada |
| Merz Investigational Site #420024 | Ostrava-Poruba | 70852 | Czechia |
| Merz Investigational Site #420031 | Ostrava-Vitkovice | 70384 | Czechia |
| Merz Investigational Site #420030 | Prague | 12000 | Czechia |
| Merz Investigational Site #420047 | Rychnov nad Kněžnou | 51601 | Czechia |
| Merz Investigational Site #033018 | Garches | 92380 | France |
| Merz Investigational Site #033024 | Rennes | 35043 | France |
| Merz Investigational Site #049022 | Beelitz-Heilstätten | 14547 | Germany |
| Merz Investigational Site #049071 | Düsseldorf | 40225 | Germany |
| Merz Investigational Site #049079 | Hamburg | 20246 | Germany |
| Merz Investigational Site #049304 | Kiel | 24105 | Germany |
| Merz Investigational Site #049072 | München | 80804 | Germany |
| Merz Investigational Site #049148 | München | 81675 | Germany |
| Merz Investigational Site #049303 | Regensburg | 93053 | Germany |
| Merz Investigational Site #049302 | Würzburg | 97080 | Germany |
| Merz Investigational Site #039006 | Messina | 98125 | Italy |
| Merz Investigational Site #039011 | Roma | 00168 | Italy |
| Merz Investigational Site #039012 | Roma | 00189 | Italy |
| Merz Investigational Site #048057 | Gdansk | 80-462 | Poland |
| Merz Investigational Site #048044 | Kielce | 25-103 | Poland |
| Merz Investigational Site #048080 | Krakow | 30-349 | Poland |
| Merz Investigational Site #048054 | Krakow | 30-510 | Poland |
| Merz Investigational Site #048031 | Krakow | 31-505 | Poland |
| Merz Investigational Site #048022 | Lodz | 90-130 | Poland |
| Merz Investigational Site #048051 | Lublin | 20-022 | Poland |
| Merz Investigational Site #048053 | Poznan | 61-485 | Poland |
| Merz Investigational Site #048081 | Poznan | 61-853 | Poland |
| Merz Investigational Site #048055 | Warsaw | 01-697 | Poland |
| Merz Investigational Site #048023 | Warsaw | 02-957 | Poland |
| Merz Investigational Site #048056 | Warsaw | 02097 | Poland |
| Merz Investigational Site #048033 | Warsaw | 04-749 | Poland |
| Merz Investigational Site #007010 | Krasnoyarsk | 660037 | Russia |
| Merz Investigational Site #007011 | Moscow | 105005 | Russia |
| Merz Investigational Site #007009 | Saint Petersburg | 129019 | Russia |
| Merz Investigational Site #007012 | Stavropol | 355000 | Russia |
| Merz Investigational Site #034027 | Madrid | 28040 | Spain |
| Merz Investigational Site #034028 | Majadahonda | 28222 | Spain |
| Merz Investigational Site #034026 | Seville | 41009 | Spain |
| Merz Investigational Site #034030 | Seville | 41013 | Spain |
| Merz Investigational Site #034029 | Terrassa | 08221 | Spain |
| FG001 | Placebo | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Extension Period |
|
|
The Safety Evaluation Set (SES) is the subset of all subjects who were exposed to Investigational product (IP) in the main period at least once.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Main Period: IncobotulinumtoxinA (Xeomin) 400 Units | IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection. |
| BG001 | Main Period: Placebo | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection |
| 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 |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| 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 | Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4 | The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 4 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12 | A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure. | The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once. | Posted | Number | Percentage of Participants | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS) | Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | The FAS included subjects in SES of main period for whom primary efficacy variable was available, whereby SES is subset of all subjects who were exposed to IP in main period at least once. Here, "N"(Number of Participants Analyzed) and "n" signifies those participants who were evaluable for this outcome measure and at given time point respectively. | Posted | Number | Percentage of Participants | Week 4, 8, and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits | The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Here, 'n' specifies those subjects who were evaluated for this outcome measure at given time point. | The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4, 8, and 12 |
|
From time point of first injection until 120 +/- 7 days after last administration of injection
The investigator asked the subject for adverse events systematically at each visit.
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 | Main Period: IncobotulinumtoxinA (Xeomin) 400 Units | IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection. | 6 | 144 | 13 | 144 | ||
| EG001 | Main Period: Placebo | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection | 5 | 145 | 13 | 145 | ||
| EG002 | Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units | IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection. | 22 | 269 | 31 | 269 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epilepsy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Intracranial haematoma | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Cranioplasty | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Desmoid tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Medical induction of coma | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| Skin lesion excision | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| Tracheostomy | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| Limb operation | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| Rehabilitation therapy | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Upper-limb fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Personality disorder | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Immobile | Social circumstances | MedDRA 18.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| γ-glutamyltransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the Investigator will consider these doubts in the publication as long as the scientific neutrality is not affected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals GmbH | +49 69 1503 1 | clinicaltrials@merz.de |
| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Death |
|
| Lost to Follow-up |
|
| Non-compliance |
|
| Predefined discontinuation criteria |
|
| Male |
|
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|
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| OG001 |
| Placebo |
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection |
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