NCT01910363

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

6 months

First QC Date

July 18, 2013

Last Update Submit

January 9, 2014

Conditions

Lower Limb Spasticity After Stroke

Keywords

poststroke spasticitylower limbbotulinum toxinA2

Outcome Measures

Primary Outcomes (1)

  • 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

    30-60 days after injection

Secondary Outcomes (1)

  • Change in Functional Independence Measure (FIM)

    30 days after injection

Other Outcomes (2)

  • Walking Speed for 3m

    30 days after injection

  • grasp power

    30 days after injection

Study Arms (2)

A2NTX

EXPERIMENTAL

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

Drug: A2NTX

BOTOX

ACTIVE COMPARATOR

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

Drug: BOTOX

Interventions

A2NTXDRUG

Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.

Also known as: A2NTX:low molecular weight (150kDalton) purified botulinum toxin type A2 preparation
A2NTX
BOTOXDRUG

Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.

Also known as: BOTOX®:onabotulinumtoxinA (Allergan Co Ltd), commercially available botulinum toxin type A1
BOTOX

Eligibility Criteria

Age40 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with lower limb spasticity after stroke
  • duration more than 6 months
  • Modified Ashworth Scale of ankle joint more than 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokushima University Hospital

Tokushima, Tokushima, 770-8503, Japan

Location

Related Publications (1)

  • 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.

    PMID: 26394198DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chairman, Department of Neurology

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 29, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2014

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

JP(1)