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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 4-6 weeks after xeomin injection
Awards & highlights

Study Summary

This trial is testing whether Xeomin can help improve mobility in people with hemiparesis.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Instrumented Timed Up and Go test time
Secondary outcome measures
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
8%
Headache
7%
Muscular weakness
6%
Neck pain
6%
Fall
6%
Nasopharyngitis
6%
Upper respiratory tract infection
4%
Back pain
4%
Nausea
4%
Dizziness
4%
Sinusitis
2%
Arthralgia
2%
Musculoskeletal pain
1%
Completed suicide
1%
Leukocytosis
1%
Gait disturbance
1%
Ankle fracture
1%
Vascular graft thrombosis
1%
Basal cell carcinoma
1%
Acute respiratory failure
1%
Hypoxia
1%
Pulmonary oedema
1%
Colon operation
1%
Anaphylactic reaction
1%
Peripheral artery stenosis
1%
Peripheral ischaemia
1%
Diplopia
1%
Pneumonia
1%
Kidney infection
1%
Ovarian cyst
1%
Colon cancer stage III
1%
Contusion
1%
Bronchioloalveolar carcinoma
1%
Duodenal ulcer haemorrhage
1%
Syncope
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Xeomin Short Flex
Xeomin Long Flex

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

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,247 Total Patients Enrolled
12 Trials studying Stroke
13,177 Patients Enrolled for Stroke
Merz Pharmaceuticals GmbHIndustry Sponsor
74 Previous Clinical Trials
13,343 Total Patients Enrolled
5 Trials studying Stroke
1,611 Patients Enrolled for Stroke
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,834 Total Patients Enrolled
2 Trials studying Stroke
67 Patients Enrolled for Stroke

Media Library

Xeomin® Clinical Trial Eligibility Overview. Trial Name: NCT04908423 — Phase 4
Stroke Research Study Groups: Xeomin®
Stroke Clinical Trial 2023: Xeomin® Highlights & Side Effects. Trial Name: NCT04908423 — Phase 4
Xeomin® 2023 Treatment Timeline for Medical Study. Trial Name: NCT04908423 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is this clinical trial particularly suitable?

"Eligible applicants should experience stroke, be between 18 and 79 years old, and join the clinical trial's cohort of 20 participants."

Answered by AI

Are investigators still seeking participants for this research?

"This research study is actively recruiting, as indicated by its presence on clinicaltrials.gov. The trial was inaugurated October 19th 2021 and the latest changes were made April 19th 2022."

Answered by AI

Are seniors aged 70 and above able to partake in this study?

"To participate in this trial, applicants must be between 18 and 79 years old. In contrast, there are 44 clinical trials specifically targeting minors while 1060 studies focus on elderly participants."

Answered by AI

In what clinical scenarios is Xeomin® typically prescribed?

"Xeomin® is a clinically tested medication for treating urinary incontinence. It has also been proven effective in the management of spinal cord injury, botox injections and overactive bladder syndrome (OABs)."

Answered by AI

Are there any additional research initiatives that have examined Xeomin®?

"Presently, Xeomin® is the subject of 61 active clinical trials with 20 in Phase 3. Although Farmington Hills, Michigan serves as a major hub for these studies, they are taking place at 759 distinct medical centres around the world."

Answered by AI

How many participants can take part in this experiment at any given time?

"Yes, the clinicaltrials.gov website states that this investigation is still recruiting participants. It was first made public on October 19th 2021 and an update to it's details occurred April 19th 2022. The study will include 20 people from a single location."

Answered by AI

Has Xeomin® been accepted by the FDA?

"Xeomin® is deemed safe and secure, with a rating of 3. This assessment stems from the fact that this therapy has been given approval for Phase 4 trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Xeomin® and Gait Related Mobility After Stroke
Mark Newman 2021. "Xeomin® and Gait Related Mobility After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04908423.
~9 spots leftby Apr 2026
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