NCT01910363

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Tokushima · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lower Limb Spasticity After Stroke

Interventions

Type	Name	Description
DRUG	A2NTX	Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
DRUG	BOTOX	Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-01-01
• First posted: 2013-07-29
• Last updated: 2014-01-10

Locations

1 site across 1 country: Japan