CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
IncobotulinumtoxinA +1 moredrug
Likely dose
IncobotulinumtoxinA 300 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03044080
NCT03044080Phase 4Completed
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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

Parc de Salut Mar·interventional·Posted Feb 6, 2017·Updated Oct 20, 2017

In Brief

A Phase 4 clinical trial evaluating IncobotulinumtoxinA and OnabotulinumtoxinA for Stroke Rehabilitation and Stroke Rehabilitation Spasticity Management. Completed, enrolled 20 participants across 1 site.

Detailed 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®).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke Rehabilitation, Stroke Rehabilitation Spasticity Management
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 6, 2017
Enrollment StartJan 1, 2015
Primary CompletionJun 30, 2017
Study CompletionSep 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.4 years ago

Interventions

IncobotulinumtoxinAdrug

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.

OnabotulinumtoxinAdrug

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.