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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
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Lower Limb Spasticity After Stroke Drug: A2NTX Drug: BOTOX Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Clinical Efficacy of Botulinum Neurotoxin Type A1 and A2 for Post-Stroke Lower Limb Spasticity: Phase 2/3
Study Start Date : July 2013
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arms and Interventions

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 Name: 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
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

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Change in Functional Independence Measure (FIM) [ Time Frame: 30 days after injection ]

Other Outcome Measures:
  1. 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.

  2. 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.

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910363

Tokushima University Hospital
Tokushima, Japan, 770-8503
Sponsors and Collaborators
University of Tokushima
Ministry of Health, Labour and Welfare, Japan
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ryuji Kaji, Professor and Chairman, Department of Neurology, University of Tokushima
ClinicalTrials.gov Identifier: NCT01910363     History of Changes
Other Study ID Numbers: A1A2BONT
TU001 ( Other Grant/Funding Number: Tokushima University )
First Posted: July 29, 2013    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014

Keywords provided by Ryuji Kaji, University of Tokushima:
poststroke spasticity
lower limb
botulinum toxin

Additional relevant MeSH terms:
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents