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The purpose of this study is to evaluate the safety and efficacy of Botulax® compared to Botox® reducing upper limb muscle tone in post stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin type A(Botulax®) | Experimental | Botulinum toxin type A |
|
| Botulinum toxin type A(Botox®) | Active Comparator | Botulinum toxin type A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A(Botulax®) | Biological | IM, total dose of 360 Units at wrist flexor, elbow flexor, finger flexor, and thumb flexor based on muscle tone |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in MAS(Modified Ashworth Scale) grade | The change in MAS (Modified Ashworth Scale) grade from baseline at week 4 for wrist flexor muscle tone | from baseline at week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in muscle tone on MAS (Modified Ashworth Scale)for elbow, finger, and thumb flexor | from baseline at week 4 | |
| The change in muscle tone on MAS (Modified Ashworth Scale)for wrist, elbow, finger, and thumb flexor | from baseline at week 8 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with diagnosed neuromuscular disorders such as Lamber-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
Patients with profound atrophy of the muscle in the target limb
Patients with fixed joint/muscle contracture* in the target limb
Patients with history within 6 months or planned to have treatment with phenol or alcohol injection(chemodenervation) in the target limb
Patients with history within 6 months or planned to have treatment with tendon lengthening in the target limb
Patients who have concurrent treatment with an intrathecal baclofen
Patients who had received Botulinum toxin injection within the past 3 months(for cosmetic purpose is allowed)
Patients with concurrent or planned to take muscle relaxants and/or benzodiazepine medication (Allowed to participate if patient has consistently taken these medication from a month before screening visit and no changes in therapy are planned during the study)
Patients with concurrent or planned to have physical, occupational, or splinting therapy (Allowed to participate if these therapies were consistently taken from a month before screening visit and no treatment changes are planned during the study
Patients with a known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.)
Patients who have participated in other clinical trials 1 month prior to this study
Male and Female who are not willing to take any appropriate means of contraception or to have ascetic life at least 2 months after treatment
Patients who are not eligible for this study at the discretion of the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Min-ho Chun, Ph.D. | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Incheon St. Mary's hospital | Incheon | Incheon | South Korea | |||
| Seoul National University Hospital |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botulinum toxin type A(Botox®) | Biological |
|
| The change in DAS (Disability Assessment Scale) grade for the principal therapeutic target | from baseline at week 4, 8, 12 |
| Global assessment evaluated by investigator | at week 4, 8, 12 |
| Global assessment evaluated by patients | at week 4, 8, 12 |
| The change in carer burden on Caregiver Burden Scale evaluated by caregiver | from baseline at week 4, 8, 12 |
| Bundang |
| Kyunggi |
| South Korea |
| Asan Medical Center | Seoul | Seoul | South Korea |
| Chung Ang University Hospital | Seoul | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | Seoul | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | Seoul | South Korea |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |