Overview

This trial is active, not recruiting.

Condition lower limb spasticity after stroke
Treatments a2ntx, botox
Phase phase 2/phase 3
Sponsor University of Tokushima
Collaborator Ministry of Health, Labour and Welfare, Japan
Start date July 2013
End date January 2014
Trial size 30 participants
Trial identifier NCT01910363, A1A2BONT, TU001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2
a2ntx A2NTX:low molecular weight (150kDalton) purified botulinum toxin type A2 preparation
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
(Active Comparator)
single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1
botox BOTOX®:onabotulinumtoxinA (Allergan Co Ltd), commercially available botulinum toxin type A1
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.

Primary Outcomes

Measure
Change in Modified Ashworth Scale of the ankle joint
time frame: 30-60 days after injection

Secondary Outcomes

Measure
Change in Functional Independence Measure (FIM)
time frame: 30 days after injection

Eligibility Criteria

Male or female participants from 40 years up to 79 years old.

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

Additional Information

Official title Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by University of Tokushima.