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Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke (A2NTX)

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ClinicalTrials.gov Identifier: NCT01910363
Recruitment Status : Unknown
Verified January 2014 by Ryuji Kaji, University of Tokushima.
Recruitment status was:  Active, not recruiting
First Posted : July 29, 2013
Last Update Posted : January 10, 2014
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Ryuji Kaji, University of Tokushima

Tracking Information
First Submitted Date  ICMJE July 18, 2013
First Posted Date  ICMJE July 29, 2013
Last Update Posted Date January 10, 2014
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2013)
Change in Functional Independence Measure (FIM) [ Time Frame: 30 days after injection ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 26, 2013)
  • Walking Speed for 3m [ Time Frame: 30 days after injection ]
    Time required for a patient to stand up from sitting position in a chair of 50cm height and walk for 3m. If assistance is needed, the same method of assisting the patient is used throughout the study.
  • grasp power [ Time Frame: 30 days after injection ]
    Grasping power of both upper limbs will be measure with a standard grasp measure device in kg units. Because injection is made into lower limbs, any decrease of grasp power will be assessed as the measure of unwanted spread of the toxin action.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
Official Title  ICMJE Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lower Limb Spasticity After Stroke
Intervention  ICMJE
  • Drug: A2NTX
    Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
    Other Name: A2NTX:low molecular weight (150kDalton) purified botulinum toxin type A2 preparation
  • Drug: 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 Name: BOTOX®:onabotulinumtoxinA (Allergan Co Ltd), commercially available botulinum toxin type A1
Study Arms  ICMJE
  • Experimental: A2NTX
    single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2
    Intervention: Drug: A2NTX
  • Active Comparator: BOTOX
    single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1
    Intervention: Drug: BOTOX
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 26, 2013)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01910363
Other Study ID Numbers  ICMJE A1A2BONT
TU001 ( Other Grant/Funding Number: Tokushima University )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ryuji Kaji, University of Tokushima
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Tokushima
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ministry of Health, Labour and Welfare, Japan
Investigators  ICMJE Not Provided
PRS Account University of Tokushima
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP