Xeomin® for Post-Stroke Mobility

Overseen by Mark A Hirsch, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Hearing impairment, Orthopedic injuries, Aphasia, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether Xeomin® injections can help adults with one-sided weakness walk better. The study will measure walking ability using two common tests. Xeomin® works by relaxing muscles, which may make it easier for these patients to move.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot have had botulinum toxin treatment in the past 4 months.

What data supports the effectiveness of the drug Xeomin® for improving mobility after a stroke?

Research shows that Xeomin® (incobotulinumtoxinA) is effective in reducing muscle stiffness (spasticity) in both upper and lower limbs after a stroke, which can help improve movement. Studies have demonstrated improvements in walking speed and reduction in pain, indicating better overall mobility. ^{1 2 3 4 5}

Is Xeomin® safe for human use?

Xeomin® (incobotulinumtoxinA) has been shown to be generally safe for treating various conditions like spasticity, blepharospasm, and cervical dystonia. It is a purified form of botulinum toxin type A, and studies have found it to have good tolerability with no reported cases of therapy failure due to antibodies. ^{1 2 3 5 6}

How is the drug Xeomin® unique for post-stroke mobility?

Xeomin® is unique because it is a purified form of botulinum toxin type A that is free from complexing proteins, which may reduce the risk of immune response and improve tolerability. It has shown effectiveness in treating spasticity (muscle stiffness) in both upper and lower limbs, which can help improve mobility after a stroke. ^{1 2 3 4 5}

Research Team

Mark A Hirsch, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults who have had a stroke, resulting in hemiparesis and spasticity but can walk at least 10 meters unaided. They shouldn't have had surgery on the lower limb or botulinum toxin treatment within 4 months. Excluded are those with severe communication deficits, lack of body position sense, joint contractures, other major neurological conditions or acute illnesses, limited joint movement, hearing issues or unsafe weight-bearing.

Inclusion Criteria

I can walk 10 meters on my own without help or devices.

I have not had surgery on my legs.

I can lift my toes off the ground when walking without help.

Exclusion Criteria

I have difficulty speaking or understanding language.

I can't move my ankle, knee, or elbow more than a little bit.

I have permanent stiffness in my arms or legs that cannot be straightened.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Xeomin® injection into the upper limb and are evaluated using physical function tests

4-6 weeks

1 visit (in-person) for injection, follow-up assessments

Follow-up

Participants are contacted for an end of study visit via telephone to obtain information regarding any adverse events and gain insight into the therapeutic duration of the Xeomin®

12 weeks post-injection

1 visit (telephone)

Treatment Details

Interventions

• Xeomin® (Neurotoxin)

Trial Overview The study tests whether Xeomin® injections improve walking ability in stroke survivors with arm and leg muscle stiffness. Participants' gait mobility will be measured before and after treatment using the '10-meter walk test' and 'timed up and go' test to assess changes in their physical function during rehabilitation.

Participant Groups

Group I: Xeomin® Experimental Treatment 1 Intervention

Participants will be injected via electromyographic guidance with a total of 200 units of Xeomin® into the pectoralis major, biceps brachii, brachioradialis, and latissimus dorsi muscles of the hemiparetic side using a standardized injection protocol (16). An additional 100 units of Xeomin® will be available at the discretion of the investigator for injection into additional affected upper extremity muscles

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Atrium Health

Lead Sponsor

Trials

122

Recruited

34,900+

Eugene A. Woods

Atrium Health

Chief Executive Officer since 2016

MPP from Harvard University

Dr. Rasu B. Shrestha

Atrium Health

Chief Medical Officer since 2019

MD from CCS University, MBA from Marshall School of Business, University of Southern California

Merz Pharmaceuticals GmbH

Industry Sponsor

Trials

75

Recruited

13,400+

Stefan König

Merz Pharmaceuticals GmbH

Chief Executive Officer since 2023

Diploma degree from Berufsakademie Ravensburg, degree from Georgia State University, and post-graduate studies at Tecnológico de Monterrey

Dr. Stefan Albrecht

Merz Pharmaceuticals GmbH

Chief Medical Officer since 2010

Board-certified neurologist

Findings from Research

IncobotulinumtoxinA (Xeomin) has been shown to be effective and well-tolerated for treating neurological conditions like blepharospasm, cervical dystonia, and post-stroke spasticity, based on randomized controlled trials lasting up to 89 weeks.

The safety profile of incobotulinumtoxinA is favorable, with mild to moderate adverse events such as eyelid ptosis and dry eye, and it has demonstrated therapeutic equivalence to another formulation, onabotulinumtoxinA, in treating blepharospasm and cervical dystonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders. Jost, WH., Benecke, R., Hauschke, D., et al.[2018]

IncobotulinumtoxinA (Xeomin®) was found to be effective in reducing lower limb spasticity in post-stroke patients, showing a significant improvement in the Modified Ashworth Scale score compared to placebo in a study of 208 subjects over 12 weeks.

The treatment was well-tolerated with no new safety concerns, and continued efficacy was observed with repeated injections in an open-label extension phase, indicating its potential for flexible treatment intervals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects. Masakado, Y., Kagaya, H., Kondo, K., et al.[2022]

IncobotulinumtoxinA (Xeomin®) is shown to be a well-tolerated treatment for focal spasticity in children with cerebral palsy, based on a retrospective study of 69 children who received a total of 191 injections.

While 37.5% of injections resulted in adverse effects, most were mild, with injection pain being the most common; only three were considered directly related to the treatment, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for the treatment of spasticity in children with cerebral palsy - a retrospective case series focusing on dosing and tolerability. León-Valenzuela, A., Palacios, JS., Del Pino Algarrada, R.[2020]

In a case study of a 67-year-old woman with chronic hemiparesis due to stroke, injections of Xeomin® significantly improved shoulder pain and walking velocity, with assessments showing positive changes in spasticity and overall function after 1 month.

No adverse events were reported, indicating that Xeomin® is a safe option for alleviating functional impairments related to chronic spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional influence of botulinum neurotoxin type A treatment (Xeomin®) of multifocal upper and lower limb spasticity on chronic hemiparetic gait. Falso, M., Galluso, R., Malvicini, A.[2021]

Incobotulinumtoxin-A is a cost-effective treatment for blepharospasm and cervical dystonia compared to onabotulinumtoxin-A, with incremental costs per quality-adjusted life-year of A$ 25,588 and A$ 23,794, respectively, based on a 5-year Markov model analysis.

The flexible treatment intervals for incobotulinumtoxin-A allow for better symptom management, resulting in patients experiencing fewer weeks of symptoms compared to the fixed 12-week intervals required for onabotulinumtoxin-A.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Incobotulinumtoxin-A with Flexible Treatment Intervals Compared to Onabotulinumtoxin-A in the Management of Blepharospasm and Cervical Dystonia. Tilden, D., Guarnieri, C.[2018]

IncobotulinumtoxinA (Xeomin) has a longer shelf life and simpler storage requirements compared to traditional botulinum toxin products, indicating that it can remain stable without complexing proteins, which may also reduce the risk of immune reactions.

Clinical studies have demonstrated Xeomin's efficacy in treating conditions like cervical dystonia and blepharospasm, and it has shown a lower incidence of antibody-induced therapy failure, suggesting improved safety and effectiveness over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year experience with incobotulinumtoxinA (Xeomin(®) ): the first botulinum toxin drug free of complexing proteins. Dressler, D.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects. [2022]

3. England pubmed.ncbi.nlm.nih.gov

IncobotulinumtoxinA for the treatment of spasticity in children with cerebral palsy - a retrospective case series focusing on dosing and tolerability. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Functional influence of botulinum neurotoxin type A treatment (Xeomin®) of multifocal upper and lower limb spasticity on chronic hemiparetic gait. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Incobotulinumtoxin-A with Flexible Treatment Intervals Compared to Onabotulinumtoxin-A in the Management of Blepharospasm and Cervical Dystonia. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Five-year experience with incobotulinumtoxinA (Xeomin(®) ): the first botulinum toxin drug free of complexing proteins. [2022]