Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot

October 19, 2017 updated by: Esther Duarte, Parc de Salut Mar

Effects of Repeated Use of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot in Stroke Patients: A Randomized Clinical Trial

Clinical randomized clinical trial to assess the effectiveness on walking speed of repeated use of botulinum neurotoxin type A (BoNT/A)in the post-stroke spastic equinovarus foot in three successive infiltrations at 6-month intervals, checking if the sustainability of the effect is greater in incobotulinumtoxin A (Xeomin®) than in onabotulinumtoxinA (Botox®).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spasticity is present in 38% of patients at six months after stroke. Equinovarus foot, with or without claw toes and striatal foot, is especially common. There is a weak to moderate evidence in favor of the use of botulinum neurotoxin type A (BoNT/A) in the equinovarus foot, stiff-knee and in other patterns that may interfere with gait ability. Specifically, BoNT/A increases walking speed in stroke patients with spastic equinovarus foot.

Repeated use of BoNT/A may lead to the appearance of neutralizing antibodies, so its effect may decrease over successive infiltrations. Among the differential characteristics of incobotulinumtoxinA (Xeomin®) there is a reduced inactivated botulinum neurotoxin content and the lack of complexing proteins, which would diminish antigenicity and not suppose a decrease of the effect before successive infiltrations.

The objective of this project is to determine the effect on walking speed of repeated use of BoNT/A in post-stroke spinal equinovarus foot in three consecutive injections at 6-month intervals and to investigate whether the sustainability of the effect is greater in incobotulinumtoxinA (Xeomin®) than in onabotulinumtoxinA (Botox®). All patients will receive 200-300 units of BoNT/A (Xeomin ® or Botox ®) that will be distributed according to the individual clinical pattern of spastic equinovarus foot.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

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

  • Spain
      • Barcelona, Spain, 08024
        • Hospital de l'Esperança

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First-ever Ischemic or haemorrhagic stroke
  • Time since stroke onset: >6months
  • Hemiparesis with equinovarus foot
  • No previous BoNT/A

Exclusion Criteria:

  • Non-ambulant patients
  • Medical contraindications for BoNT/A use that appear in the product information sheet

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: IncobotulinumtoxinA
Injection of 200-300 units of IncobotulinumtoxinA (Xeomin ®)
Drug: IncobotulinumtoxinA
Three consecutive injections of 200-300 units of IncobotulinumtoxinA (Xeomin ®) under ultrasound guidance. The IncobotulinumtoxinA will be distributed according to the individual clinical pattern of spasticity: plantar flexor muscles (triceps sural: gastrocnemius and soleus), tibialis posterior, flexor digitorum longus.
ACTIVE_COMPARATOR: OnabotulinumtoxinA
Injection of 200-300 units of onabotulinumtoxiA (Botox®)
Drug: OnabotulinumtoxinA
ree consecutive injections of 200-300 units of OnabotulinumtoxinA (Botox ®) under ultrasound guidance. The BoNT/A will be distributed according to the individual clinical pattern of spasticity: plantar flexor muscles (triceps sural: gastrocnemius and soleus), tibialis posterior, flexor digitorum longus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in walking speed
Time Frame: Baseline and monthly during 18 months
Walking speed, expressed in m/s, is assessed in a 10-m corridor
Baseline and monthly during 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in spasticity assessed with the Modified Ashworth Scale
Time Frame: Baseline and monthly during 18 months
Spasticity assessed with the Modified Ashworth Scale (range 0-5)
Baseline and monthly during 18 months
Change in walking disability assessed with the Scandinavian Stroke Scale
Time Frame: Baseline and monthly during 18 months
Walking disability is assessed with the Scandinavian Stroke Scale
Baseline and monthly during 18 months
Change in functional ambulation ability assessed with the Modified Walking Categories
Time Frame: Baseline and monthly during 18 months
Functional ambulation ability is assessed with the Modified Walking Categories
Baseline and monthly during 18 months
Change in step time
Time Frame: Baseline and monthly during 18 months
Step time (Temporal gait parameter) is expressed in seconds and assessed with instrumented gait analysis
Baseline and monthly during 18 months
Change in step length
Time Frame: Baseline and monthly during 18 months
Step length (Spatial gait parameter) is expressed in meters and assessed with instrumented gait analysis
Baseline and monthly during 18 months

Collaborators and Investigators

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

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Esther Duarte, PhD, Fundació IMIM - Parc de Salut Mar

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 (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

September 30, 2017

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 3, 2017

First Posted (ESTIMATE)

February 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSM/RHB/NR22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Stroke Rehabilitation

Clinical Trials on IncobotulinumtoxinA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe