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

January 9, 2014 updated by: Ryuji Kaji, University of Tokushima

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A2NTX
single intramuscular injection of 300 units of A2NTX, a purified low molecular weight (150 kDalton) botulinum toxin preparation of type A2
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 Names:
  • A2NTX:low molecular weight (150kDalton) purified botulinum toxin type A2 preparation
Active Comparator: BOTOX
single intramuscular injection of 300 units of BOTOX®, a commercially available botulinum toxin preparation of type A1
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 Names:
  • BOTOX®:onabotulinumtoxinA (Allergan Co Ltd), commercially available botulinum toxin type A1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30-60 days after injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Functional Independence Measure (FIM)
Time Frame: 30 days after injection
30 days after injection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days after injection
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.
30 days after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tokushima

Collaborators

Ministry of Health, Labour and Welfare, Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimate)

July 29, 2013

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1A2BONT
  • TU001 (Other Grant/Funding Number: Tokushima University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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