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

NCT03044080 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-10-20

No results posted yet for this study

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®).

Conditions

  • Stroke Rehabilitation
  • Stroke Rehabilitation Spasticity Management

Interventions

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.

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.

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Esther Duarte, PhD · Fundació IMIM - Parc de Salut Mar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03044080 on ClinicalTrials.gov