Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- University of Tokushima
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in Modified Ashworth Scale of the ankle joint
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A2NTX
single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2
Intervention: A2NTX (Drug)
BOTOX
single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1
Intervention: BOTOX (Drug)
Outcomes
Primary Outcomes
Change in Modified Ashworth Scale of the ankle joint
Time Frame: 30-60 days after injection
Modified Ashworth Scale is measured at baseline, 30(27-33) days and 60 (56-63) days after injection. Area under curve of Modified Ashworth Scale changes at day 30 and day 60 after injection
Secondary Outcomes
- Change in Functional Independence Measure (FIM)(30 days after injection)
Investigators
Ryuji Kaji
Professor and Chairman, Department of Neurology
University of Tokushima