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

Parc de Salut Mar

Status and phase: Completed; Phase 4

Conditions: Stroke Rehabilitation Spasticity Management; Stroke Rehabilitation

Treatments: Drug: IncobotulinumtoxinA; Drug: OnabotulinumtoxinA

Study type: Interventional

Funder types: Other

Identifiers

NCT03044080

PSM/RHB/NR22

Details and patient eligibility

About

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®).

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

IncobotulinumtoxinA

Active Comparator group

Description:

Injection of 200-300 units of IncobotulinumtoxinA (Xeomin ®)

Treatment:

Drug: IncobotulinumtoxinA

OnabotulinumtoxinA

Active Comparator group

Description:

Injection of 200-300 units of onabotulinumtoxiA (Botox®)

Treatment:

Drug: OnabotulinumtoxinA