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

Sponsor

Parc de Salut Mar (Other)

Overall Status

Completed

CT.gov ID

NCT03044080

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel assignmentParallel 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 :

Jan 1, 2015

Actual Primary Completion Date :

Jun 30, 2017

Actual Study Completion Date :

Sep 30, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in walking speed [Baseline and monthly during 18 months]
Walking speed, expressed in m/s, is assessed in a 10-m corridor

Secondary Outcome Measures

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