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

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

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.

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