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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Tokushima
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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