Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
This trial is active, not recruiting.
|Condition||lower limb spasticity after stroke|
|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|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Change in Modified Ashworth Scale of the ankle joint
time frame: 30-60 days after injection
Change in Functional Independence Measure (FIM)
time frame: 30 days after injection
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
|Official title||Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3|
Call for more information