Lower Limb Spasticity After Stroke Clinical Trial
— A2NTXOfficial title:
Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
| Verified date | January 2014 |
| Source | University of Tokushima |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for
treating stroke patients with lower limb spasticity.
- we study the degree of spasticity in the ankle and knee joints, and walking speed in 30
patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded
manner as for the patient, the physician, and the examiner.
- we also assess the safety of A2NTX and compare it to that of BOTOX.
| Status | Unknown status |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 79 Years |
| Eligibility |
Inclusion Criteria: - patients with lower limb spasticity after stroke - duration more than 6 months - Modified Ashworth Scale of ankle joint more than 2 Exclusion Criteria: - patients with previous botulinum toxin injections to lower limbs - patients with serious hepatic, renal or cardiac dysfunction - patients with respiratory failure - patients who cannot understand the instructions |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Tokushima University Hospital | Tokushima |
| Lead Sponsor | Collaborator |
|---|---|
| University of Tokushima | Ministry of Health, Labour and Welfare, Japan |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| Other | grasp power | 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 | |
| Primary | 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 | |
| Secondary | Change in Functional Independence Measure (FIM) | 30 days after injection |