Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
NCT ID: NCT01910363
Last Updated: 2014-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2013-07-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A2NTX
single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2
A2NTX
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
BOTOX
single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1
BOTOX
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
Interventions
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A2NTX
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
BOTOX
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* duration more than 6 months
* Modified Ashworth Scale of ankle joint more than 2
Exclusion Criteria
* patients with serious hepatic, renal or cardiac dysfunction
* patients with respiratory failure
* patients who cannot understand the instructions
40 Years
79 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
University of Tokushima
OTHER
Responsible Party
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Ryuji Kaji
Professor and Chairman, Department of Neurology
Locations
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Tokushima University Hospital
Tokushima, Tokushima, Japan
Countries
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References
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Kaji R. Clinical differences between A1 and A2 botulinum toxin subtypes. Toxicon. 2015 Dec 1;107(Pt A):85-8. doi: 10.1016/j.toxicon.2015.09.025. Epub 2015 Sep 21.
Other Identifiers
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TU001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
A1A2BONT
Identifier Type: -
Identifier Source: org_study_id
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