Xeomin® for Post-Stroke Mobility

Overseen By Kiandra Austrie, RN, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Hearing impairment, Orthopedic injuries, Aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4-6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well Xeomin®, a botulinum toxin, improves walking ability in people with movement difficulties after a stroke. Researchers aim to determine if injecting Xeomin® into specific muscles can make walking smoother and faster by comparing results from two walking tests before and after treatment. Individuals who have had a stroke, experience difficulty on one side of their body, and can walk at least 10 meters without assistance might be suitable candidates. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for Xeomin®?

Research has shown that Xeomin® (incobotulinumtoxinA) is generally safe for treating muscle stiffness after a stroke. Studies have found that even at higher doses, up to 800 units, Xeomin® remains safe and well-tolerated, with no serious side effects reported. Specifically, one study found that a dose of 400 units was both effective and well-tolerated for treating stiffness in the upper limbs.

In simpler terms, many people with muscle stiffness after a stroke have safely used Xeomin®. The treatment helps improve movement by relaxing tight muscles and has a strong safety record when used as directed. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for post-stroke mobility issues, which often include physical therapy and other botulinum toxin injections, Xeomin® is injected with precision using electromyographic guidance. This method ensures that the medication targets the specific muscles most affected by the stroke, potentially improving effectiveness. Additionally, Xeomin® is a purified form of botulinum toxin type A, free from unnecessary proteins, which may reduce the risk of developing resistance. Researchers are particularly excited about Xeomin® because its targeted approach and unique formulation could offer enhanced results for muscle relaxation and movement improvement in stroke patients.

What evidence suggests that Xeomin® might be an effective treatment for post-stroke mobility?

Research shows that Xeomin® effectively reduces muscle stiffness, known as spasticity, after a stroke. Studies have found that it leads to lasting improvements in muscle tone and helps reduce disability. It also aids in daily tasks like dressing and enhances the quality of life for stroke survivors. Xeomin® improves movement in both arms and legs, which is crucial for better walking and overall mobility after a stroke. The treatment carries a low risk of complications and can be reversed, making it a safe choice for many. Overall, Xeomin® is a proven treatment for reducing muscle problems and improving movement after a stroke. ^{1 3 6 7 8}

Who Is on the Research Team?

Mark A Hirsch, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Xeomin®

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.

How Is the Trial Designed?

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+

Atrium Health

Lead Sponsor

Trials

122

Recruited

34,900+

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

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4737345/

Safety and efficacy of incobotulinumtoxinA as a potential ... Since 1989, BoNT-A has been shown to be effective in reducing spasticity after stroke with reversibility and low prevalence of complications ...

2. medicaljournals.se medicaljournals.se/jrm/content/html/10.2340/16501977-2760

Sustained efficacy of incobotulinumtoxina repeated ... Conclusion: IncobotulinumtoxinA conferred sustained improvements in muscle tone, disability, and caregiver burden in subjects with upper-limb post-stroke ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10821091/

Improvement in Quality-of-Life-Related Outcomes Following ... This pooled analysis showed that incobotulinumtoxinA significantly improves QoL-related outcomes, such as upper limb positioning abnormality and dressing- and ...

4. withpower.com withpower.com/trial/phase-4-stroke-9-2021-e24e1

Xeomin® for Post-Stroke Mobility It has shown effectiveness in treating spasticity (muscle stiffness) in both upper and lower limbs, which can help improve mobility after a stroke.

5. neurology.org neurology.org/doi/10.1212/WNL.86.16_supplement.P3.303

Sustained Efficacy with IncobotulinumtoxinA in Upper-Limb ... Objective: To assess the efficacy and safety of incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals GmbH) for upper-limb post-stroke ...

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000003789

Safety and efficacy of incobotulinumtoxinA doses up to 800 ... Escalating incobotulinumtoxinA doses (400 U up to 800 U) did not compromise safety or tolerability, enabled treatment in a greater number of muscles/spasticity ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.832937/full

Efficacy and Safety of IncobotulinumtoxinA in the Treatment ... Conclusion: This study demonstrated that incobotulinumtoxinA (total dose 400 U) is an effective and a well-tolerated treatment for LL spasticity ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04908423

Xeomin® and Gait Related Mobility After Stroke Participants will be tested on the primary and secondary outcome measures before upper extremity injection with Xeomin® and 4 to 6 weeks thereafter.