iovera° System for Muscle Spasms

Recruiting at 18 trial locations

Overseen By Heakyung Kim, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pacira Pharmaceuticals, Inc

Must be taking: Oral baclofen

Must not be taking: Neurotoxins, Phenol, Ethyl alcohol

Disqualifiers: Stroke, Brain injury, Spinal injury, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the iovera° system, a medical device, to determine its safety and effectiveness for individuals with muscle spasms in the shoulder and elbow, often resulting from past brain or spinal injuries. The trial compares the real treatment to a sham to assess any genuine benefits. Individuals who have experienced muscle tightness in their upper limbs for at least six months and are not undergoing medication changes may be suitable candidates. The trial aims to determine if this device can improve daily life for those with muscle control issues. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for muscle spasms.

Do I have to stop taking my current medications for the trial?

If you are taking oral medications for spasticity, you must keep the dose stable for at least 4 weeks before the study. If you use an intrathecal baclofen pump, the dose must be stable for six months before the study.

What prior data suggests that the iovera° system is safe for treating muscle spasms?

Research has shown that the iovera° system, which uses cold to treat nerve tissue, is very safe. Studies have found that it can block or relieve pain without drugs for up to 90 days. The FDA has approved it for pain relief in areas like the knee, hip, shoulder, and spine, indicating it has passed several safety tests for these uses.

In past studies, the iovera° system was used safely and effectively, making it a promising option for treating muscle spasms. As this treatment progresses through more advanced trial phases, additional safety data suggests that it is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for muscle spasms, which often involve medications like muscle relaxants or physical therapy, the iovera° System uses a novel approach by targeting nerves with precise cold therapy, known as cryoneurolysis. This method temporarily interrupts nerve signals without the need for drugs, potentially reducing the risk of side effects associated with medication. Researchers are excited about the iovera° System because it offers a non-invasive, drug-free alternative that might provide rapid relief from muscle spasms, potentially improving patient comfort and quality of life.

What evidence suggests that the iovera° system is effective for muscle spasms?

Research shows that the iovera° system, which participants in this trial may receive, effectively relieves pain and reduces muscle spasms. Studies have found that it provides quick and long-lasting pain relief, which may also help with muscle stiffness that can make movement difficult. For example, in other conditions, the iovera° system significantly reduced pain and its impact on daily life during follow-up visits. The system achieves this through cryoneurolysis, where cold is applied to specific nerves to temporarily stop their activity. Although data on upper arm muscle stiffness is limited, the system's ability to target nerves and ease discomfort suggests it could yield positive results. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with cerebral palsy or muscle spasms causing stiffness in the shoulder and elbow. Participants must have been diagnosed at least 6 months prior, not be on varying oral spasticity meds, or if using a baclofen pump, it should be stable for six months. They need to show improvement after a lidocaine nerve block test.

Inclusion Criteria

Subject, in the investigator's opinion, will not be exposed to unacceptable risk by participation

Able to provide informed consent, adhere to the study schedule, and complete all study assessments

I was diagnosed with a brain or spine condition causing muscle stiffness in my shoulder and elbow over 6 months ago.

Exclusion Criteria

Allergy or intolerance to amide local anesthetics

I have been diagnosed with a condition affected by cold, such as cryoglobulinemia, cold urticaria, or Raynaud's.

Subject is unable to adhere to the assessment schedule

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Treatment

Participants receive either the iovera° system treatment or sham treatment on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for efficacy and safety outcomes post-treatment

13 weeks

3 visits (in-person) at Week 3, Week 7, and Week 13

What Are the Treatments Tested in This Trial?

Interventions

• Iovera®° System

Trial Overview

The study tests the iovera° system's effectiveness and safety against sham treatment in reducing upper extremity spasticity. Of the participants, two-thirds will receive actual iovera° treatment while one-third will get a sham procedure, decided randomly.

How Is the Trial Designed?

Group I: iovera° system treatment Active Control 1 Intervention

Group II: sham iovera° system treatment Placebo Group 1 Intervention

Iovera®° System is already approved in United States for the following indications:

Approved in United States as Iovera° System for:

• Osteoarthritis (OA) knee pain
• Pain management in the hip, shoulder, chest, foot and ankle, spine
• Pain related to rib fracture and mastectomy

Who Is Running the Clinical Trial?

Pacira Pharmaceuticals, Inc

Lead Sponsor

Trials

142

Recruited

14,300+

Headquarters

Tampa, USA

Known For

Non-opioid Pain Management

Top Products

Exparel, Zilretta, iovera

Dr. Jonathan Slonin

Pacira Pharmaceuticals, Inc

Chief Medical Officer since 2020

BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University

Frank D. Lee

Pacira Pharmaceuticals, Inc

Chief Executive Officer since 2024

BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business

Published Research Related to This Trial

A new technique using accelerometers can objectively monitor and quantify muscle spasms in individuals with spinal cord injuries, distinguishing them from other movements like wheelchair use or transfers.

The method correlates well with muscle activity and allows for precise measurement of spasm duration, magnitude, and energy, making it a promising clinical tool for evaluating and treating spasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of air bag technology: an objective clinical measure of involuntary muscle spasm. Granat, MH., Edmond, P.[2019]

In a study analyzing electromyographic (EMG) records from four subjects with chronic cervical spinal cord injury, two raters showed high agreement (89%) in classifying different types of muscle spasms, indicating that EMG is a reliable method for objective spasm assessment.

Most variability in spasm counts was due to differences between muscles rather than between subjects or raters, suggesting that muscle-specific factors play a significant role in spasm occurrence and that automated software could improve consistency in spasm identification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and classification of involuntary leg muscle contractions in electromyographic records from individuals with spinal cord injury. Thomas, CK., Dididze, M., Martinez, A., et al.[2021]

Mechanical stimulation of the quadriceps muscle through sinusoidal vibrations led to significant improvements in motor performance, including a 27.8% decrease in time to develop force and a 40.3% increase in fatigue resistance in subjects performing voluntary contractions.

These results suggest that mechanical stimulation can induce lasting changes in motor control and proprioception, making it a promising tool for enhancing sports training and rehabilitation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor performance changes induced by muscle vibration. Fattorini, L., Ferraresi, A., Rodio, A., et al.[2018]

Muscular vibrations in relaxed and contracted skeletal muscles were successfully recorded using a piezo-electric device, revealing distinct frequency patterns that depend on muscle type and function.

The study suggests that these vibrations are primarily caused by the activity of motor units and central reflex loops, indicating that Computer-Vibromyography can enhance our understanding of muscle function alongside traditional EMG techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The computer-vibromyography as a biometric progress in studying muscle function. Keidel, M., Keidel, WD.[2019]

The development of integrated musculoskeletal modeling tools allows for the safe and efficient design and evaluation of controllers for functional electrical stimulation (FES) before clinical trials, enhancing research in neuromusculoskeletal systems.

The Musculoskeletal Modeling in Simulink (MMS) and virtual muscle software enable the creation of anatomically accurate models without coding, facilitating complex simulations and improving the understanding of muscle responses to FES.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced modeling environment for developing and testing FES control systems. Davoodi, R., Brown, IE., Loeb, GE.[2019]

Citations

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iovera Clinical Results | Pain Relief Outcomes

In both cases, it has been shown to provide immediate and long-lasting pain relief. Keep reading to see the study results.

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clinicaltrials.gov/study/NCT07214844

A Prospective Study to Evaluate the Efficacy of Iovera ...

A research study is being conducted to compare two treatments for long-term low back pain: One uses the iovera° system, which applies cold ...

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mountsinai.org/clinical-trials/study-to-assess-efficacy-safety-of-iovera-system-in-subjects-with-upper-extremity-spasticity

Study to Assess the Efficacy and Safety of Iovera®° System ...

This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper ...

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withpower.com

withpower.com/trial/phase-3-muscle-spasticity-2-2024-2eca0

iovera° System for Muscle Spasms

Trial Overview The study tests the iovera° system's effectiveness and safety against sham treatment in reducing upper extremity spasticity. Of the participants, ...

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ioverapro.com

ioverapro.com/tka-clinical-efficacy-data

TKA Clinical Data | iovera Pre-Surgery Results

The iovera° group demonstrated significant reductions in PROMIS pain intensity and pain interference at 2- and 6-week follow-up, respectively.

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iovera.com/risks

iovera Risks & Safety Information

Important safety information. Indication. iovera° applies freezing cold to peripheral nerve tissue to block and/or relieve pain for up to 90 days.

7.

iovera.com

iovera.com/

iovera | Non-Opioid Pain Relief Treatment

FDA-cleared iovera provides immediate pain relief using cryoneurolysis. Drug-free treatment for knee, hip, shoulder, spine & more. Lasts up to 90 days.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06340451

Study to Assess the Efficacy and Safety of Iovera®° System ...

This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with ...

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accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/k161835.pdf

K161835 Trade/Device Name: iovera - accessdata.fda.gov

Use of the already cleared iovera° system in the Clinical Study described herein has shown that the device can be used safely and effectively, ...