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

NCT03044080 | Completed Phase 4

• 1 other identifier: PSM/RHB/NR22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Walking Disorder; Stroke; Botulinum Toxin; Spasticity

Outcome Measures

Primary Outcomes (1)

• Change in walking speed

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

  Baseline and monthly during 18 months

Secondary Outcomes (5)

• Change in spasticity assessed with the Modified Ashworth Scale

  Baseline and monthly during 18 months

• Change in walking disability assessed with the Scandinavian Stroke Scale

  Baseline and monthly during 18 months

• Change in functional ambulation ability assessed with the Modified Walking Categories

  Baseline and monthly during 18 months

• Change in step time

  Baseline and monthly during 18 months

• Change in step length

  Baseline and monthly during 18 months

Study Arms (2)

IncobotulinumtoxinA

ACTIVE COMPARATOR

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

Drug: IncobotulinumtoxinA

OnabotulinumtoxinA

ACTIVE COMPARATOR

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

Drug: OnabotulinumtoxinA

Interventions

IncobotulinumtoxinA DRUG

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.

IncobotulinumtoxinA

OnabotulinumtoxinA DRUG

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.

OnabotulinumtoxinA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital de l'Esperança

Barcelona, 08024, Spain

Location

Related Publications (4)

• 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.

  PMID: 14684785 BACKGROUND

• 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.

  PMID: 12194622 BACKGROUND

• 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.

  PMID: 20491885 BACKGROUND

• 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.

  PMID: 22035051 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Esther Duarte, PhD

  Fundació IMIM - Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehabilitation Research Group Coordinator, PhD

Model Details: Parallel assignment

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 6, 2017
• Study Start: January 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: September 30, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)