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| Name | Class |
|---|---|
| LLC Merz Pharma, Russia | UNKNOWN |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xeomin® | Experimental | 4-8 Units per kg body weight. Single injection cycle. |
|
| Botox® | Active Comparator | 4-6(8) Units per kg body weight. Single injection cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xeomin | Drug | Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS) | The AS is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). | From baseline to day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in patient percentage in groups by the degree of gastrocnemius spasticity according to modified Ashworth scale | From baseline up to day 90 | |
| Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | LLC Merz Pharma, Russia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Budget Institution of Health in Moscow "Scientific and Practical Center of Pediatric psychoneurology Moscow Health Department" | Moscow | 119602 | Russia |
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| Botox® | Drug | Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius. |
|
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Electromyography: The amplitude of a compound muscle action potential (M-wave) is recorded. An electrical stimulation is considered supramaximal when the M-wave amplitude no longer increases while increasing the stimulus. The measurements include the M-wave amplitude and the negative peak area of the M-wave.
| From baseline up to day 90 |
| Changes from baseline in the ratio of M-response recorded from the lateral and medial gastrocnemius heads and from tibialis anterior | From baseline up to day 90 |
| Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension | From baseline up to day 90 |
| Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria | GMFCS is a 5-level classification system that is a standardized observational instrument for children with CP developed to measure change in gross motor function over time. | From baseline up to day 90 |
| Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale | Baseline up to day 90 |
| Federal State Autonomous Institution "Scientific Center of Children's Health" of the Ministry of Health of the Russian Federation | Moscow | 119991 | Russia |
| Federal State Budget Educational Institution of Higher Professional Learning "Stavropol State Medical University" of the Ministry of Health of the Russian Federation | Stavropol | 355017 | Russia |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D010264 | Paraplegia |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
| 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 |
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