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

Phase 2

• Conditions: Lower Limb Spasticity After Stroke
• Interventions: Drug: A2NTX; Drug: BOTOX

• Registration Number: NCT01910363
• Lead Sponsor: University of Tokushima

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-29
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A2NTX	A2NTX	single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2
BOTOX	BOTOX	single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1

Primary Outcome Measures

Name	Time	Method
Change in Modified Ashworth Scale of the ankle joint	30-60 days after injection	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

Secondary Outcome Measures

Name	Time	Method
Change in Functional Independence Measure (FIM)	30 days after injection

Trial Locations

Locations (1)

Tokushima University Hospital; 🇯🇵 Tokushima, Japan