What side effects are associated with this type of intervention?

Botulinum Toxin Type A, such as Xeomin®, is commonly used to reduce muscle spasticity in stroke patients by temporarily paralyzing muscles. Known side effects include localized pain at the injection site, muscle weakness, and flu-like symptoms. In some cases, patients may experience dry mouth, fatigue, and dysphagia (difficulty swallowing). Rare but serious side effects can include allergic reactions and the development of neutralizing antibodies, which may reduce the effectiveness of the treatment over time.

What prior FDA approvals exist?

The FDA has approved several botulinum toxin type A products for the treatment of muscle spasticity, including Botox®, Dysport®, and Xeomin®. These treatments work by temporarily paralyzing muscles to reduce spasticity, which is a common issue following a stroke. Botox® (onabotulinumtoxinA) was one of the first to receive approval for this indication, followed by Dysport® (abobotulinumtoxinA) and Xeomin® (incobotulinumtoxinA). These treatments are typically administered via intramuscular injections and have been shown to improve mobility and reduce muscle stiffness in stroke patients.

What other types of research exist?

Promising alternatives to Xeomin® for treating muscle spasticity in stroke patients include: 1) Other botulinum toxin formulations such as onabotulinumtoxinA (Botox®) and abobotulinumtoxinA (Dysport®), which have similar mechanisms of action. 2) Oral medications like baclofen, tizanidine, and dantrolene, which are muscle relaxants used to manage spasticity. 3) Intrathecal baclofen therapy, which delivers medication directly to the spinal fluid for severe spasticity. 4) Non-pharmacological interventions such as physical therapy, occupational therapy, and functional electrical stimulation (FES), which can help improve muscle function and reduce spasticity. 5) Emerging technologies like transcutaneous electrical nerve stimulation (TENS) and neuromodulation devices, which have shown potential in reducing spasticity through non-invasive means.

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Xeomin® for Post-Stroke Mobility

Phase 4

Recruiting

Led By Mark A Newman, PhD, MPH

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to walk at least 10 meters without physical assistance from another person and without an assistive device

No prior surgery to the lower limb

Must not have

Speech language expression deficit (e.g., aphasia)

Passive range of motion at either the ankle, knee, or elbow joint less than 30 degrees

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4-6 weeks after xeomin injection

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated here, common side effects of Xeomin® may include injection site reactions such as pain or bruising, muscle weakness near where the medicine was injected, drooping eyelids, trouble swallowing or breathing if muscles that control these functions are affected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have not had surgery on my legs.

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

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I have muscle stiffness and weakness on one side of my body due to a stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty speaking or understanding language.

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

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

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I cannot safely walk, even with help, due to an injury.

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I do not have any other major neurological conditions or active serious illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4-6 weeks after xeomin injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 4-6 weeks after xeomin injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4-6 weeks after xeomin injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Instrumented Timed Up and Go test time

Secondary study objectives

Change in Activities-Specific Balance (ABC) Scale score

Change in Berg Balance Scale (BBS) score

Change in Brief Pain Inventory (BPI) - Short Form score

+6 more

Side effects data

From 2016 Phase 4 trial • 283 Patients • NCT01486264

25%

Dysphagia

Headache

Muscular weakness

Neck pain

Fall

Nasopharyngitis

Upper respiratory tract infection

Back pain

Nausea

Dizziness

Sinusitis

Arthralgia

Musculoskeletal pain

Completed suicide

Leukocytosis

Gait disturbance

Ankle fracture

Vascular graft thrombosis

Basal cell carcinoma

Acute respiratory failure

Hypoxia

Pulmonary oedema

Colon operation

Anaphylactic reaction

Peripheral artery stenosis

Peripheral ischaemia

Diplopia

Pneumonia

Kidney infection

Ovarian cyst

Colon cancer stage III

Contusion

Bronchioloalveolar carcinoma

Duodenal ulcer haemorrhage

Syncope

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Xeomin Short Flex

Xeomin Long Flex

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Xeomin®Experimental Treatment1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Xeomin®

2012

Completed Phase 4

~1030

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Botulinum Toxin Type A, such as Xeomin®, works by temporarily paralyzing muscles to reduce spasticity, which is a common issue for stroke patients. This reduction in muscle spasticity can lead to improved mobility, decreased pain, and better overall function. Other common treatments for stroke include physical therapy to enhance motor skills and strength, medications to manage symptoms and prevent further strokes, and sometimes surgical interventions to address specific complications. These treatments are crucial for improving the quality of life and functional outcomes for stroke patients.