Botulinum Toxin A for Peripheral Neuropathy

Overseen By Meghann Sytsma, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical College of Wisconsin

Must not be taking: Chemotherapy, Botulinum Toxin A

Disqualifiers: Renal disease, Pregnancy, Other neuropathy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat nerve pain caused by chemotherapy in breast cancer patients. It tests whether injecting IncobotulinumtoxinA (INA), a form of botulinum toxin A, can reduce this pain. Participants will receive either the INA treatment or a placebo (a harmless substance) to compare results. Eligible candidates include those who have undergone chemotherapy for breast cancer and experience nerve pain that began within six months of treatment. The goal is to determine if the INA treatment improves pain and overall quality of life compared to the placebo. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot have changes in neuropathic pain modulators within 1 month before joining or during the trial. You can use rescue medications for breakthrough pain if needed, as decided by your doctor.

Is there any evidence suggesting that IncobotulinumtoxinA is likely to be safe for humans?

Research has shown that IncobotulinumtoxinA (INA), also known as Xeomin®, is safe. In trials with 908 participants, 466 received Xeomin, and most tolerated it well. Some possible side effects include the toxin's effects spreading beyond the injection site, but these are usually mild and temporary.

Xeomin is already approved for other uses, such as treating chronic drooling in children and muscle stiffness in adults, indicating that health authorities have found it safe for humans. Individual experiences can differ, so discussing any concerns with the clinical trial team is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peripheral neuropathy?

Unlike the standard treatments for peripheral neuropathy, which often involve medications like pain relievers, antidepressants, or anticonvulsants, IncobotulinumtoxinA (Xeomin®) offers a novel approach by using botulinum toxin A. This treatment is unique because it directly targets the nerves responsible for pain through localized injections, potentially providing relief more precisely and with fewer systemic side effects. Researchers are excited about this treatment because it could offer a more effective, targeted option for managing neuropathic pain, particularly for patients who have not found relief with traditional therapies.

What evidence suggests that IncobotulinumtoxinA might be an effective treatment for peripheral neuropathy?

Research has shown that IncobotulinumtoxinA (INA), which participants in this trial may receive, can help treat nerve pain. Studies have found that this treatment can relieve pain for several months in conditions like chemotherapy-induced peripheral neuropathy (CIPN). For example, in other types of nerve pain, patients reported feeling less pain and experiencing a better quality of life after receiving INA. The treatment works by blocking certain chemical messengers that send pain signals in the body. Overall, promising evidence suggests that INA might help reduce pain for those dealing with CIPN. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for breast cancer patients who have undergone taxane-based chemotherapy and are experiencing neuropathic pain within 6 months of treatment. Participants must be adults over 18, score >4 on the DN4 scale for neuropathic pain, and able to consent. Excluded are those with end-stage renal disease, pregnant or breastfeeding women, prior peripheral neuropathy causes other than chemotherapy, recent Botulinum Toxin A treatment or changes in pain medication.

Inclusion Criteria

I have breast cancer and have been treated with taxane-based chemotherapy.

Patients who score >4 on the DN4 scale

I am over 18 years old.

Exclusion Criteria

I have nerve damage not caused by chemotherapy.

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

I am currently on chemotherapy or finished it within the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive intradermal injections of INA or placebo into the bilateral hands or feet

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• IncobotulinumtoxinA (Xeomin®, Merz)

Trial Overview The study tests if IncobotulinumtoxinA (INA) injections can relieve chemotherapy-induced peripheral neuropathy (CIPN) better than saline placebo. Forty participants will be randomly assigned to receive either INA or saline injections into hands/feet sites. Pain levels will be measured using the Neuropathic Pain Scale before and after eight weeks of intervention.

How Is the Trial Designed?

Group I: IncobotulinumtoxinA Experimental Treatment 1 Intervention

IncobotulinumtoxinA (Xeomin®, Merz) (INA) will be reconstituted with preservative-free normal saline to a dilution of 5mL:100 units. Study participants in this arm will receive 50u INA (total volume 2.5mL) injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Hands: INA will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Feet: INA will be injected across the dorsal surface of the feet also in a grid like pattern covering a total of 25 sites per limb (0.1mL/site).

Group II: saline control Placebo Group 1 Intervention

Study participants in this arm will 2.5mL normal saline injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Hands: saline will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Feet: Saline will be injected across the dorsal surface of the feet also in a grid like pattern covering a total of 25 sites per limb (0.1mL/site).

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10806716/

Perineural injections of incobotulinumtoxin-A for diabetic ... The authors describe the treatment as safe, well tolerated and effective, with responders reporting sufficient pain relief for 3 to 4 months ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06036043

Botulinum Toxin for Chronic Neuropathic Pain Treatment of peripheral neuropathic pain with Botulinum Toxin (BoNT) has showed promising results since the first study was released in 2001.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3116796/

Profile of Xeomin® (incobotulinumtoxinA) for the treatment ... BoNT is highly effective and well tolerated in the symptomatic treatment of a very broad range of conditions involving either muscle hyperactivity such as ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2020.00716/full

Botulinum Neurotoxin for the Treatment of Neuropathic Pain BoNT/A (doses up to 100 U, intramuscularly or subcutaneously) proved effective in reducing pain and improving quality of life in eight out of 12 female cancer ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0041010124001491

Perineural Injections of IncobotulinumtoxinA for Diabetic ... We aim to investigate the safety, efficacy, and effects on quality of life (QoL), physical activity, depressive symptoms, and activities of daily living (ADL)

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/125360s078lbl.pdf

XEOMIN (incobotulinumtoxinA) - accessdata.fda.gov 5.1 Spread of Toxin Effect. Postmarketing safety data from XEOMIN and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases ...

7. hcp.xeomin.com hcp.xeomin.com/patients/conditions/

Conditions - Xeomin Safety and effectiveness have been established in pediatric patients 2 to 17 years of age in patients with chronic sialorrhea and upper limb spasticity.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf

Xeomin - accessdata.fda.gov Postmarketing safety data from XEOMIN and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases,b e observed beyond the ...

9. ema.europa.eu ema.europa.eu/en/documents/referral/xeomin-article-29-referral-annex-i-ii-iii_en.pdf

Xeomin and associated names, INN-Clostridium botulinum ... Overall, safety data from 908 participants have been included in these trials, 466 subjects were treated with Xeomin and 442 subjects were treated with Botox.

10. hcp.xeomin.com hcp.xeomin.com/healthcare-professionals/

XEOMIN® Information For HCPs - Dosing, Efficacy & Safety The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These ...