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

University of Tokushima

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Lower Limb Spasticity After Stroke

Treatments: Drug: A2NTX; Drug: BOTOX

Study type: Interventional

Funder types: Other

Identifiers

NCT01910363

A1A2BONT

TU001 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

A2NTX

Experimental group

Description:

single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2

Treatment:

Drug: A2NTX

BOTOX

Active Comparator group

Description:

single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1

Treatment:

Drug: BOTOX