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

Stroke Rehabilitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044080
• Other study ID #: PSM/RHB/NR22
• Status: Completed
• Phase: Phase 4
• First received: February 1, 2017
• Last updated: October 19, 2017
• Start date: January 1, 2015
• Est. completion date: September 30, 2017

Study information

• Verified date: February 2017
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity
• Muscle Spasticity
• Stroke
• Stroke Rehabilitation
• Stroke Rehabilitation Spasticity Management

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital de l'Esperança	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Dressler D. Five-year experience with incobotulinumtoxinA (Xeomin(®) ): 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. Review. — View 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. Review. — View 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. Epub 2003 Dec 18. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in walking speed	Walking speed, expressed in m/s, is assessed in a 10-m corridor	Baseline and monthly during 18 months
Secondary	Change in spasticity assessed with the Modified Ashworth Scale	Spasticity assessed with the Modified Ashworth Scale (range 0-5)	Baseline and monthly during 18 months
Secondary	Change in walking disability assessed with the Scandinavian Stroke Scale	Walking disability is assessed with the Scandinavian Stroke Scale	Baseline and monthly during 18 months
Secondary	Change in functional ambulation ability assessed with the Modified Walking Categories	Functional ambulation ability is assessed with the Modified Walking Categories	Baseline and monthly during 18 months
Secondary	Change in step time	Step time (Temporal gait parameter) is expressed in seconds and assessed with instrumented gait analysis	Baseline and monthly during 18 months
Secondary	Change in step length	Step length (Spatial gait parameter) is expressed in meters and assessed with instrumented gait analysis	Baseline and monthly during 18 months