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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Ryuji Kaji, University of Tokushima
ClinicalTrials.gov Identifier:
NCT01910363
First received: July 18, 2013
Last updated: January 9, 2014
Last verified: January 2014

July 18, 2013
January 9, 2014
July 2013
January 2014   (final data collection date for primary outcome measure)
Change in Modified Ashworth Scale of the ankle joint [ Time Frame: 30-60 days after injection ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01910363 on ClinicalTrials.gov Archive Site
Change in Functional Independence Measure (FIM) [ Time Frame: 30 days after injection ] [ Designated as safety issue: No ]
Same as current
  • Walking Speed for 3m [ Time Frame: 30 days after injection ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]
    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.
Same as current
 
Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lower Limb Spasticity After Stroke
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
January 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01910363
A1A2BONT, TU001
No
Ryuji Kaji, University of Tokushima
University of Tokushima
Ministry of Health, Labour and Welfare, Japan
Not Provided
University of Tokushima
January 2014

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