Status:
UNKNOWN
Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
Lead Sponsor:
University of Tokushima
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Lower Limb Spasticity After Stroke
Eligibility:
All Genders
40-79 years
Phase:
PHASE2
PHASE3
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 kne...
Eligibility Criteria
Inclusion
- patients with lower limb spasticity after stroke
- duration more than 6 months
- Modified Ashworth Scale of ankle joint more than 2
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01910363
Start Date
July 1 2013
Last Update
January 10 2014
Active Locations (1)
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1
Tokushima University Hospital
Tokushima, Tokushima, Japan, 770-8503