Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity

April 7, 2026 updated by: Pacira Pharmaceuticals, Inc

A Multicenter, Randomized, Double-Blind, Sham-Controlled Study Assessing the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity

This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The screening and treatment may occur on the same day or be separated by as much as 30 days. All screening procedures must be completed, and criteria must be met before a subject is randomly assigned in the study. After random allocation to treatment, the subject will be scheduled for treatment (Day 1).

For all subjects, a Baseline (Day 1, pretreatment) Modified Ashworth Scale (MAS) score, Modified Tardieu Scale, and Goal Attainment Scale (GAS) score will be assessed and recorded before treatment on Day 1 (treatment day).

On Day 1 (treatment day), subjects will be reassessed for eligibility and randomly assigned in a blinded fashion (2:1) to receive either the iovera° system treatment or sham treatment. The study device will be used per the iovera° system User Guide on subjects who are prepared with local anesthetic (lidocaine 1%) only.

Local anesthetic will be injected subcutaneously into the treatment area. Ultrasound guidance will then be used to identify the specific target nerves to be studied. The targets of treatment are the medial and lateral pectoral nerves, and musculocutaneous nerve (motor branches to brachialis, and biceps brachii). A catheter will be used to guide the device needle. All subjects will have all target nerves treated. Nerve stimulation will also be employed as needed to assist in making an accurate determination regarding the location of the target nerves of interest. Up to two unblinded (1 primary and 1 backup) study staff (trained in the iovera° system treatment under ultrasound guidance) will be assigned per site to perform the study treatment procedures unless approved in advance in writing by the Sponsor on a case-by-case basis. The designated unblinded study staff must not participate in any other study-related assessments following treatment.

Each subject will be followed for 13 weeks post-treatment. The follow-up visits will be conducted at Week 3/Day 21 (±3), Week 7/Day 49 (±3), and Week 13/Day 91 (±5). Subjects will be assessed for efficacy and safety outcomes parameters.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Downey, California, United States, 90242
        • Recruiting
        • Rancho Los Amigos National Rehabilitation Center
        • Contact:
        • Principal Investigator:
          • Ziyad Ayyoub, MD
      • Santa Monica, California, United States, 90403
        • Recruiting
        • Source Healthcare - Santa Monica
        • Principal Investigator:
          • Timothy Davis, MD
        • Contact:
    • Florida
      • Bradenton, Florida, United States, 34209
      • Sarasota, Florida, United States, 34239-2921
        • Recruiting
        • Sarasota Memorial Hospital (SMH)
        • Contact:
        • Principal Investigator:
          • Ryan Hafner, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas Institute of Research - Kansas City Bone & Joint Clinic
        • Contact:
    • Missouri
      • Columbia, Missouri, United States, 65212-0001
        • Recruiting
        • University of Missouri Health Care - University Hospital
        • Contact:
        • Principal Investigator:
          • Joseph Burris, MD
      • St Louis, Missouri, United States, 63110-1032
        • Active, not recruiting
        • Washington University School of Medicine
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper University Healthcare
        • Principal Investigator:
          • Michael Saulino, MD
        • Contact:
    • New York
      • New York, New York, United States, 10029-6501
        • Active, not recruiting
        • Mount Sinai Health System - Faculty Practice Associates (FPA)
    • Pennsylvania
      • Elkins Park, Pennsylvania, United States, 19027
        • Recruiting
        • Moss Rehab Physical Medicine Associates
        • Principal Investigator:
          • Alberto Esquenazi, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital
        • Principal Investigator:
          • Michael Munin, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Heakyung Kim, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Health Houston/TIRR
        • Principal Investigator:
          • Sheng Li, MD
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23238
        • Recruiting
        • Virginia iSpine Physicians, PC
        • Principal Investigator:
          • Michael DePalma, MD
        • Contact:
    • Washington
      • Spokane, Washington, United States, 99202
        • Recruiting
        • St. Luke's Rehabilitation Institute/Main Campus
        • Principal Investigator:
          • Carolyn Black, MD
        • Contact:
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Recruiting
        • Center for Neurological Disorders - Gamma Therapeutic Center
        • Contact:
          • Christopher Cronsell, MD
      • Milwaukee, Wisconsin, United States, 53226-3548
        • Recruiting
        • Froedtert and Medical College of Wisconsin - Milwaukee
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, 18 years and above.
  2. A confirmed diagnosis of any cerebral or spinal condition, at least 6 months before Screening, resulting in spasticity of the muscles controlling the shoulder and elbow.
  3. Not on oral medications for spasticity management or if on any oral medications, the oral medication taken chronically for spasticity management (eg, oral baclofen) must be maintained at a stable dose for at least 4 weeks before screening for the study.
  4. Not on an intrathecal baclofen pump or if on an intrathecal baclofen pump for spasticity management, must be maintained at a stable dose for six months or more before screening for the study.
  5. Must have a score on the Modified Ashworth Scale of 2 or more in the targeted area (shoulder and elbow) at Screening and at Baseline (Day-1 pretreatment).
  6. A diagnostic nerve block using lidocaine (1% lidocaine, 2 to 3 mL per target nerve) showing a positive response (at least one point reduction from the screening Modified Ashworth Scale score for elbow extension and shoulder abduction) to the targeted nerves, should be performed within 30 days to at least 6 hours before study treatment. The diagnostic nerve block effect must be completely resolved before pretreatment evaluation and the study treatment.
  7. Subject, in the investigator's opinion, will not be exposed to unacceptable risk by participation.
  8. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.

Exclusion Criteria:

  1. History of stroke, traumatic brain injury, and/or spinal cord injury in less than 6 months.
  2. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, or Raynaud's disease.
  3. History of neurotoxin injections within the past 3 months.
  4. Previous injection with phenol or ethyl alcohol at any time in the target areas (shoulder or elbow).
  5. Previous surgical intervention that altered the target neuroanatomy of the upper limb.
  6. Current or planned enrollment in an investigational drug or device study for the management of spasticity for the duration of the study.
  7. Medical instability that interferes with tolerability to spasticity treatment with the study device as per the investigator's discretion.
  8. Any hospitalization within 4 weeks before Screening
  9. Diagnosis of amyotrophic lateral sclerosis or any lower motor neuron conditions
  10. Allergy or intolerance to amide local anesthetics.
  11. Any skin condition in or around the target area that, in the opinion of the investigator, could adversely impact treatment.
  12. Currently pregnant, nursing, or planning to become pregnant during the study.
  13. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  14. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
  15. Subject, in the opinion of the investigator, is not a suitable candidate for study participation (eg, history of multiple missed office visits, any related upper limb injury).
  16. Subject is unable to adhere to the assessment schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: iovera° system treatment
Device: iovera° system
subjects will receive ultrasound-guided iovera° system treatment
Sham Comparator: sham iovera° system treatment
Device: sham iovera° system treatment
subjects will receive ultrasound-guided iovera° sham system treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Modified Ashworth Scale score for elbow measured (0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity)
Time Frame: at week 13
at week 13

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction)
Time Frame: at week 13
at week 13
Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured
Time Frame: at week 13
at week 13
Change from baseline in the Modified Tardieu Scales for elbow (0 to 5, where lower score represents no resistance, and higher score represents joint immobility; Increase in angle from baseline [R1, and R2] represents improvement)
Time Frame: at week 13
at week 13
Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff (-2 to +2, where lower score represents less expected outcomes, and higher scores represent greater expected outcomes)
Time Frame: at week 13
at week 13

Other Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Modified Tardieu Scales for elbow measured immediately (within 3 hours)
Time Frame: at Day 1 post-treatment, Week 3, and Week 7.
at Day 1 post-treatment, Week 3, and Week 7.
Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction) measured immediately (within 3 hours)
Time Frame: at Day 1 post-treatment, Week 3, Week 7, and Week 13
at Day 1 post-treatment, Week 3, Week 7, and Week 13
Change from baseline in the Modified Tardieu Scales for shoulder (forward flexion, external rotation) measured immediately (within 3 hours)
Time Frame: at Day 1 post-treatment, Week 3, Week 7, and Week 13
at Day 1 post-treatment, Week 3, Week 7, and Week 13
Change from baseline in the Modified Ashworth Scale score for elbow measured immediately (within 3 hours)
Time Frame: at Day 1 post-treatment, Week 3, and Week 7
at Day 1 post-treatment, Week 3, and Week 7
Change from baseline in the Modified Ashworth Scale score for shoulder (shoulder abduction) measured immediately (within 3 hours)
Time Frame: at Day 1 post-treatment, Week 3, and Week 7
at Day 1 post-treatment, Week 3, and Week 7
Change from baseline in the Modified Ashworth Scale score for shoulder (forward flexion, external rotation) measured immediately (within 3 hours)
Time Frame: at Day 1 post-treatment, Week 3, and Week 7
at Day 1 post-treatment, Week 3, and Week 7
Change from baseline in the Modified Ashworth Scale score over 13 weeks post-treatment measured by area under the curve (AUC) for elbow (elbow extension)
Time Frame: at week 13
at week 13
Change from baseline in the Modified Ashworth Scale score over 13 weeks post-treatment measured by AUC for shoulder (shoulder abduction, shoulder forward flexion, external rotation)
Time Frame: at week 13
at week 13
Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff
Time Frame: at Week 3, and Week 7
at Week 3, and Week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacira Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOV-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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