Overseen ByMark A Newman, PhD, MPH
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.
12345Is 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.
12356How 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.
12345Eligibility 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.
+2 more
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.
+4 more
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)
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Carolinas RehabilitationCharlotte, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
Atrium HealthLead Sponsor
Merz Pharmaceuticals GmbHIndustry Sponsor
References
Clinical and pharmacological properties of incobotulinumtoxinA and its use in neurological disorders. [2018]IncobotulinumtoxinA (Xeomin(®)) is a purified botulinum neurotoxin type A formulation, free from complexing proteins, with proven efficacy and good tolerability for the treatment of neurological conditions such as blepharospasm, cervical dystonia (CD), and post-stroke spasticity of the upper limb. This article provides a comprehensive overview of incobotulinumtoxinA based on randomized controlled trials and prospective clinical studies.
Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Lower Limb Spasticity in Japanese Subjects. [2022]To confirm the efficacy and safety of incobotulinumtoxinA (Xeomin®, Merz Pharmaceuticals GmbH; total dose 400 U) in Japanese subjects with lower limb (LL) poststroke spasticity using the Modified Ashworth Scale spasticity score for the plantar flexors (MAS-PF).
IncobotulinumtoxinA for the treatment of spasticity in children with cerebral palsy - a retrospective case series focusing on dosing and tolerability. [2020]IncobotulinumtoxinA (Xeomin®) is a botulinum neurotoxin type A with established efficacy in the treatment of upper-limb spasticity in adults. This retrospective case series in a university hospital setting aimed to elucidate the safety and tolerability of incobotulinumtoxinA for treatment of spasticity in children with cerebral palsy.
Functional influence of botulinum neurotoxin type A treatment (Xeomin®) of multifocal upper and lower limb spasticity on chronic hemiparetic gait. [2021]This report describes the modification of hemiplegic shoulder pain and walking velocity through injections of Xeomin®, a new botulinum neurotoxin type A formulation, in a 67-year-old woman with chronic residual left hemiparesis and hemiparetic gait attributable to stroke. Clinical evaluation included upper and lower limb spasticity, upper and lower limb pain, trunk control, upper and lower limb motricity index, visual gait analysis, and gait velocity. Assessments were performed before, 1 week after, and 1 month after treatment. Improvement was observed in all clinical parameters assessed. Amelioration of spasticity of the upper and lower limbs and shoulder pain was observed after 1 month. Trunk postural attitude and paraxial muscle recruitment recovered. No adverse events were observed and the patient shows significant improvement of functional impairment derived from chronic spasticity after treatment with Xeomin®. We also provide a simple and useful protocol for clinical evaluation of the treatment.
Cost-Effectiveness of Incobotulinumtoxin-A with Flexible Treatment Intervals Compared to Onabotulinumtoxin-A in the Management of Blepharospasm and Cervical Dystonia. [2018]Incobotulinumtoxin-A (Xeomin(®), Merz Pharmaceuticals, Sydney, New South Wales) is a formulation of botulinum neurotoxin type A that is free of complexing proteins.
Five-year experience with incobotulinumtoxinA (Xeomin(®) ): the first botulinum toxin drug free of complexing proteins. [2022]In 2005, incobotulinumtoxinA (Xeomin(®) ), a new botulinum toxin (BT) type A drug without complexing proteins (CPs), became available. This paper reviews the specific features of Xeomin(®) and the experience gathered with it during the last 5 years. Compared with conventional BT drugs, Xeomin(®) 's extended shelf live and its simplified temperature restrictions indicate that CPs are not necessary for BT drug stability. Its reduced molecular size does not translate into diffusion differences, and its potency labelling is identical to that of onabotulinumtoxinA (Botox(®) ). With a reduced content of inactivated botulinum neurotoxin, Xeomin(®) should have reduced antigenicity. Lack of CP's may further reduce antigenicity. Xeomin(®) 's therapeutic efficacy against cervical dystonia, blepharospasm and spasticity has been proven in large randomised, double-blind and placebo-controlled studies leading to registrations in many countries. Additional successful clinical use in axillary hyperhidrosis, hemifacial spasm, re-innervation synkinesias and hypersalivation as well as in dystonia and spasticity in extended doses and throughout extended observation periods has been documented meanwhile. Lack of reported cases of antibody-induced therapy failure (ABF), as to date, support the hypothesis of an improved antigenicity.