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
  Purpose

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 Intervention Phase
Lower Limb Spasticity After Stroke
Drug: A2NTX
Drug: BOTOX
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Tokushima:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Change in Functional Independence Measure (FIM) [ Time Frame: 30 days after injection ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: July 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910363

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

No publications provided

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
Study First Received: July 18, 2013
Last Updated: January 9, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by University of Tokushima:
poststroke spasticity
lower limb
botulinum toxin
A2

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014