Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044080
Recruitment Status : Completed
First Posted : February 6, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Esther Duarte, Parc de Salut Mar

Brief Summary:
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®).

Condition or disease Intervention/treatment Phase
Stroke Rehabilitation Stroke Rehabilitation Spasticity Management Drug: IncobotulinumtoxinA Drug: OnabotulinumtoxinA Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Foot Health

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03044080


Locations
Layout table for location information
Spain
Hospital de l'Esperança
Barcelona, Spain, 08024
Sponsors and Collaborators
Parc de Salut Mar
Investigators
Layout table for investigator information
Principal Investigator: Esther Duarte, PhD Fundació IMIM - Parc de Salut Mar

Publications:
Layout table for additonal information
Responsible Party: Esther Duarte, Rehabilitation Research Group Coordinator, PhD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03044080    
Other Study ID Numbers: PSM/RHB/NR22
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esther Duarte, Parc de Salut Mar:
Walking Disorder
Stroke
Botulinum Toxin
Spasticity
Additional relevant MeSH terms:
Layout table for MeSH terms
Muscle Spasticity
Clubfoot
Stroke
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
Talipes
Foot Deformities, Acquired
Foot Deformities
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Botulinum Toxins, Type A
incobotulinumtoxinA
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors