Clinical trial NCT03044080: Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke Rehabilitation
Stroke Rehabilitation Spasticity Management
Keywords: Walking Disorder
Stroke
Botulinum Toxin
Spasticity
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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®).

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.

Eligibility 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

Primary outcomes:
measure: Change in walking speed
timeFrame: Baseline and monthly during 18 months
Secondary outcomes:
measure: Change in spasticity assessed with the Modified Ashworth Scale
timeFrame: Baseline and monthly during 18 months
measure: Change in walking disability assessed with the Scandinavian Stroke Scale
timeFrame: Baseline and monthly during 18 months
measure: Change in functional ambulation ability assessed with the Modified Walking Categories
timeFrame: Baseline and monthly during 18 months
measure: Change in step time
timeFrame: Baseline and monthly during 18 months
measure: Change in step length
timeFrame: Baseline and monthly during 18 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de l'Esperança
Study officials:
affiliation: Fundació IMIM - Parc de Salut Mar
name: Esther Duarte, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sommerfeld DK, Eek EU, Svensson AK, Holmqvist LW, von Arbin MH. Spasticity after stroke: its occurrence and association with motor impairments and activity limitations. Stroke. 2004 Jan;35(1):134-9. doi: 10.1161/01.STR.0000105386.05173.5E. Epub 2003 Dec 18.
citation: Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002 Aug;16(5):515-22. doi: 10.1191/0269215502cr512oa.
citation: Foley N, Murie-Fernandez M, Speechley M, Salter K, Sequeira K, Teasell R. Does the treatment of spastic equinovarus deformity following stroke with botulinum toxin increase gait velocity? A systematic review and meta-analysis. Eur J Neurol. 2010 Dec;17(12):1419-27. doi: 10.1111/j.1468-1331.2010.03084.x.
citation: Dressler D. Five-year experience with incobotulinumtoxinA (Xeomin((R)) ): the first botulinum toxin drug free of complexing proteins. Eur J Neurol. 2012 Mar;19(3):385-9. doi: 10.1111/j.1468-1331.2011.03559.x. Epub 2011 Oct 28.