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

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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