Actively Recruiting
Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
Led by Pacira Pharmaceuticals, Inc · Updated on 2026-04-09
132
Participants Needed
18
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years and above.
- Confirmed diagnosis of any cerebral or spinal condition causing spasticity in shoulder and elbow muscles for at least 6 months before screening.
- Not on oral spasticity medications or on stable oral medication dose for at least 4 weeks before screening.
- Not on an intrathecal baclofen pump or on stable pump dose for 6 months or more before screening.
- Modified Ashworth Scale score of 2 or more in the shoulder and elbow at screening and baseline.
- Positive response to a diagnostic nerve block with lidocaine (at least one point reduction on the Modified Ashworth Scale) done within 30 days to at least 6 hours before treatment.
- Investigator believes participation does not pose unacceptable risk.
- Able to give informed consent, follow study schedule, and complete assessments.
You will not qualify if you...
- History of stroke, traumatic brain injury, or spinal cord injury within the past 6 months.
- Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, or Raynaud's disease.
- Neurotoxin injections in the past 3 months.
- Previous injection with phenol or ethyl alcohol in the target shoulder or elbow areas.
- Prior surgery altering the upper limb nerve anatomy.
- Current or planned participation in other spasticity drug or device studies during this study.
- Medical instability interfering with treatment tolerability.
- Hospitalization within 4 weeks before screening.
- Diagnosis of amyotrophic lateral sclerosis or lower motor neuron conditions.
- Allergy or intolerance to amide local anesthetics.
- Skin conditions in the treatment area that could affect treatment.
- Currently pregnant, nursing, or planning pregnancy during the study.
- History or suspicion of drug, prescription medicine, or alcohol addiction or abuse within past 2 years.
- Uncontrolled anxiety, schizophrenia, or psychiatric disorders affecting assessments or compliance.
- Investigator considers the subject unsuitable for participation (e.g., multiple missed visits or related upper limb injury).
- Unable to follow the study assessment schedule.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
Actively Recruiting
2
Source Healthcare - Santa Monica
Santa Monica, California, United States, 90403
Actively Recruiting
3
Nova Clinical Research, LLC
Bradenton, Florida, United States, 34209
Actively Recruiting
4
Sarasota Memorial Hospital (SMH)
Sarasota, Florida, United States, 34239-2921
Actively Recruiting
5
Shepherd Center
Atlanta, Georgia, United States, 30309
Actively Recruiting
6
Kansas Institute of Research - Kansas City Bone & Joint Clinic
Overland Park, Kansas, United States, 66211
Actively Recruiting
7
University of Missouri Health Care - University Hospital
Columbia, Missouri, United States, 65212-0001
Actively Recruiting
8
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1032
Active, Not Recruiting
9
Cooper University Healthcare
Camden, New Jersey, United States, 08103
Actively Recruiting
10
Mount Sinai Health System - Faculty Practice Associates (FPA)
New York, New York, United States, 10029-6501
Active, Not Recruiting
11
Moss Rehab Physical Medicine Associates
Elkins Park, Pennsylvania, United States, 19027
Actively Recruiting
12
University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
13
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
14
University of Texas Health Houston/TIRR
Houston, Texas, United States, 77030
Actively Recruiting
15
Virginia iSpine Physicians, PC
Richmond, Virginia, United States, 23238
Actively Recruiting
16
St. Luke's Rehabilitation Institute/Main Campus
Spokane, Washington, United States, 99202
Actively Recruiting
17
Center for Neurological Disorders - Gamma Therapeutic Center
Greenfield, Wisconsin, United States, 53228
Actively Recruiting
18
Froedtert and Medical College of Wisconsin - Milwaukee
Milwaukee, Wisconsin, United States, 53226-3548
Actively Recruiting
Research Team
C
Christine K. Brozyniak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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