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

NCT06340451 | Recruiting DMC FDA Device

• 1 other identifier: IOV-301
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 18

Brief Summary

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).

Conditions

Spasticity, Cerebral or Spinal Condition

Keywords

spasticity; cerebral; Spinal

Outcome Measures

Primary Outcomes (1)

• 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)

  at week 13

Secondary Outcomes (4)

• Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured

  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)

  at week 13

• Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction)

  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)

  at week 13

Other Outcomes (9)

• Change from baseline in the Modified Ashworth Scale score for elbow measured immediately (within 3 hours)

  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)

  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)

  at Day 1 post-treatment, Week 3, and Week 7

Study Arms (2)

iovera° system treatment

ACTIVE COMPARATOR

Device: iovera° system

sham iovera° system treatment

SHAM COMPARATOR

Device: sham iovera° system treatment

Interventions

sham iovera° system treatment DEVICE

subjects will receive ultrasound-guided iovera° sham system treatment

sham iovera° system treatment

iovera° system DEVICE

subjects will receive ultrasound-guided iovera° system treatment

iovera° system treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years and above.
• 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.
• 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.
• 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.
• 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).
• 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.
• 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.

You may not qualify if:

• History of stroke, traumatic brain injury, and/or spinal cord injury in less than 6 months.
• Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, or Raynaud's disease.
• History of neurotoxin injections within the past 3 months.
• Previous injection with phenol or ethyl alcohol at any time in the target areas (shoulder or elbow).
• Previous surgical intervention that altered the target neuroanatomy of the upper limb.
• Current or planned enrollment in an investigational drug or device study for the management of spasticity for the duration of the study.
• Medical instability that interferes with tolerability to spasticity treatment with the study device as per the investigator's discretion.
• Any hospitalization within 4 weeks before Screening
• Diagnosis of amyotrophic lateral sclerosis or any lower motor neuron conditions
• Allergy or intolerance to amide local anesthetics.
• Any skin condition in or around the target area that, in the opinion of the investigator, could adversely impact treatment.
• Currently pregnant, nursing, or planning to become pregnant during the study.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
• 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).

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (18)

Rancho Los Amigos National Rehabilitation Center

Downey, California, 90242, United States

RECRUITING

Source Healthcare - Santa Monica

Santa Monica, California, 90403, United States

RECRUITING

Nova Clinical Research, LLC

Bradenton, Florida, 34209, United States

RECRUITING

Sarasota Memorial Hospital (SMH)

Sarasota, Florida, 34239-2921, United States

RECRUITING

Shepherd Center

Atlanta, Georgia, 30309, United States

RECRUITING

Kansas Institute of Research - Kansas City Bone & Joint Clinic

Overland Park, Kansas, 66211, United States

RECRUITING

University of Missouri Health Care - University Hospital

Columbia, Missouri, 65212-0001, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110-1032, United States

ACTIVE NOT RECRUITING

Cooper University Healthcare

Camden, New Jersey, 08103, United States

RECRUITING

Mount Sinai Health System - Faculty Practice Associates (FPA)

New York, New York, 10029-6501, United States

ACTIVE NOT RECRUITING

Moss Rehab Physical Medicine Associates

Elkins Park, Pennsylvania, 19027, United States

RECRUITING

University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

University of Texas Health Houston/TIRR

Houston, Texas, 77030, United States

RECRUITING

Virginia iSpine Physicians, PC

Richmond, Virginia, 23238, United States

RECRUITING

St. Luke's Rehabilitation Institute/Main Campus

Spokane, Washington, 99202, United States

RECRUITING

Center for Neurological Disorders - Gamma Therapeutic Center

Greenfield, Wisconsin, 53228, United States

RECRUITING

Froedtert and Medical College of Wisconsin - Milwaukee

Milwaukee, Wisconsin, 53226-3548, United States

RECRUITING

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christine K. Brozyniak

CONTACT

(973) 254-4364; christine.brozyniak@pacira.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (18)