Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke

Study Overview
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Brief Summary
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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. 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.

Official Title
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Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3

Conditions
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Lower Limb Spasticity After Stroke

Intervention / Treatment
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* Drug: A2NTX
* Drug: BOTOX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A2NTX<br>single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2 | Drug: A2NTX<br>* Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.<br>* Other names: A2NTX:low molecular weight (150kDalton) purified botulinum toxin type A2 preparation;|
| Active Comparator: BOTOX<br>single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1 | Drug: BOTOX<br>* Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.<br>* Other names: BOTOX®:onabotulinumtoxinA (Allergan Co Ltd), commercially available botulinum toxin type A1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Independence Measure (FIM) |  | 30 days after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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poststroke spasticity, lower limb, botulinum toxin, A2