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Stroke RehabilitationPhase 4NCT03044080

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

A Phase 4 study testing IncobotulinumtoxinA and OnabotulinumtoxinA in people with Stroke Rehabilitation and Stroke Rehabilitation Spasticity Management, run by Parc de Salut Mar at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
IncobotulinumtoxinA and OnabotulinumtoxinA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
1 Jan 2015to 30 Sep 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First-ever Ischemic or haemorrhagic stroke
  • Time since stroke onset: >6months
  • Hemiparesis with equinovarus foot
  • No previous BoNT/A

Who cannot join

  • Non-ambulant patients
  • Medical contraindications for BoNT/A use that appear in the product information sheet

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital de l'Esperança

    Barcelona, 08024

Other trials in Spain

About this study

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 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®).

Read the 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.

Being tested
IncobotulinumtoxinA, OnabotulinumtoxinA
Keywords
Walking Disorder, Stroke, Botulinum Toxin, Spasticity
Medical subject headings
Stroke, Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03044080
Study groupRoleWhat they receive
IncobotulinumtoxinAActive comparatorInjection of 200-300 units of IncobotulinumtoxinA (Xeomin ®)
Receives: Drug: IncobotulinumtoxinA
OnabotulinumtoxinAActive comparatorInjection of 200-300 units of onabotulinumtoxiA (Botox®)
Receives: Drug: OnabotulinumtoxinA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in walking speed

    Walking speed, expressed in m/s, is assessed in a 10-m corridor

    Measured: Baseline and monthly during 18 months

Secondary outcomes (5)

  1. Change in spasticity assessed with the Modified Ashworth Scale

    Spasticity assessed with the Modified Ashworth Scale (range 0-5)

    Measured: Baseline and monthly during 18 months

  2. Change in walking disability assessed with the Scandinavian Stroke Scale

    Walking disability is assessed with the Scandinavian Stroke Scale

    Measured: Baseline and monthly during 18 months

  3. Change in functional ambulation ability assessed with the Modified Walking Categories

    Functional ambulation ability is assessed with the Modified Walking Categories

    Measured: Baseline and monthly during 18 months

  4. Change in step time

    Step time (Temporal gait parameter) is expressed in seconds and assessed with instrumented gait analysis

    Measured: Baseline and monthly during 18 months

  5. Change in step length

    Step length (Spatial gait parameter) is expressed in meters and assessed with instrumented gait analysis

    Measured: Baseline and monthly during 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2017 (estimated)
  2. Study start1 Jan 2015
  3. Primary completion30 Jun 2017
  4. Study completion30 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03044080
Sponsor's protocol ID
PSM/RHB/NR22
Status last verified
Feb 2017
First submitted
1 Feb 2017
Last updated
20 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14684785

  • 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.

    PubMed 12194622

  • 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.

    PubMed 20491885

  • 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.

    PubMed 22035051

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing IncobotulinumtoxinA and OnabotulinumtoxinA in people with Stroke Rehabilitation and Stroke Rehabilitation Spasticity Management, run by Parc de Salut Mar at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in walking speed (time frame: Baseline and monthly during 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03044080, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.

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