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

Primary Purpose

Lower Limb Spasticity After Stroke

Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
A2NTX
BOTOX
Sponsored by
University of Tokushima
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Spasticity After Stroke focused on measuring poststroke spasticity, lower limb, botulinum toxin, A2

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tokushima University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A2NTX

BOTOX

Arm Description

single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2

single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1

Outcomes

Primary Outcome Measures

Change in Modified Ashworth Scale of the ankle joint
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 Outcome Measures

Change in Functional Independence Measure (FIM)

Full Information

First Posted
July 18, 2013
Last Updated
January 9, 2014
Sponsor
University of Tokushima
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT01910363
Brief Title
Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
Acronym
A2NTX
Official Title
Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tokushima
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Spasticity After Stroke
Keywords
poststroke spasticity, lower limb, botulinum toxin, A2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A2NTX
Arm Type
Experimental
Arm Description
single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2
Arm Title
BOTOX
Arm Type
Active Comparator
Arm Description
single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1
Intervention Type
Drug
Intervention Name(s)
A2NTX
Other Intervention Name(s)
A2NTX:low molecular weight (150kDalton) purified botulinum toxin type A2 preparation
Intervention Description
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
Intervention Type
Drug
Intervention Name(s)
BOTOX
Other Intervention Name(s)
BOTOX®:onabotulinumtoxinA (Allergan Co Ltd), commercially available botulinum toxin type A1
Intervention Description
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
Primary Outcome Measure Information:
Title
Change in Modified Ashworth Scale of the ankle joint
Description
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
Time Frame
30-60 days after injection
Secondary Outcome Measure Information:
Title
Change in Functional Independence Measure (FIM)
Time Frame
30 days after injection
Other Pre-specified Outcome Measures:
Title
Walking Speed for 3m
Description
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.
Time Frame
30 days after injection
Title
grasp power
Description
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.
Time Frame
30 days after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26394198
Citation
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.
Results Reference
derived

Learn more about this trial

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

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