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| ID | Type | Description | Link |
|---|---|---|---|
| TU001 | Other Grant/Funding Number | Tokushima University |
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| Name | Class |
|---|---|
| Ministry of Health, Labour and Welfare, Japan | OTHER_GOV |
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To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A2NTX | Experimental | single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2 |
|
| BOTOX | Active Comparator | single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A2NTX | Drug | Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Ashworth Scale of the ankle joint | Modified Ashworth Scale is measured at baseline, 30(27-33) days and 60 (56-63) days after injection. Area under curve of Modified Ashworth Scale changes at day 30 and day 60 after injection | 30-60 days after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Independence Measure (FIM) | 30 days after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Speed for 3m | Time required for a patient to stand up from sitting position in a chair of 50cm height and walk for 3m. If assistance is needed, the same method of assisting the patient is used throughout the study. | 30 days after injection |
| grasp power |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokushima University Hospital | Tokushima | Tokushima | 770-8503 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26394198 | Derived | Kaji R. Clinical differences between A1 and A2 botulinum toxin subtypes. Toxicon. 2015 Dec 1;107(Pt A):85-8. doi: 10.1016/j.toxicon.2015.09.025. Epub 2015 Sep 21. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 18, 2017 | |
| Unrelease | May 24, 2018 | |
| Release | May 24, 2018 | |
| Reset | Dec 14, 2018 | |
| Release | Oct 6, 2021 | |
| Reset | Nov 4, 2021 | |
| Release | Apr 25, 2022 | |
| Reset | Jan 26, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 18, 2017 | May 24, 2018 | |||
| May 24, 2018 |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| BOTOX | Drug | Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side. |
|
|
Grasping power of both upper limbs will be measure with a standard grasp measure device in kg units. Because injection is made into lower limbs, any decrease of grasp power will be assessed as the measure of unwanted spread of the toxin action. |
| 30 days after injection |
| Dec 14, 2018 |
| Oct 6, 2021 | Nov 4, 2021 |
| Apr 25, 2022 | Jan 26, 2023 |
| 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 |