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Active, not recruitingNCT06340451Updated Jul 6, 2026

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

An interventional study of iovera° system and sham iovera° system treatment in Spasticity, Cerebral or Spinal Condition, sponsored by Pacira Pharmaceuticals, Inc. Active, not recruiting at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Pacira Pharmaceuticals, Inc · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Spasticity, Cerebral or Spinal Condition

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Keywords

  • spasticity
  • cerebral
  • Spinal
03

In context

Muscle Spasticity

621 studies on the registry are indexed under Muscle Spasticity; 127 are open to participants now.

This study's planned enrollment of 132 is above the median of 36 across 472 interventional studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Pacira Pharmaceuticals, Inc is the lead sponsor of 102 studies on the registry; 3 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.

Browse Pacira BioSciences, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , adhere to the study schedule, and complete all study assessments.

Exclusion criteria

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
132 participants (estimated)

Study arms

  • Active comparator
    iovera° system treatment

    Device: iovera° system

  • Sham comparator
    sham iovera° system treatment

    Device: sham iovera° system treatment

Interventions

  • Deviceiovera° system

    subjects will receive ultrasound-guided iovera° system treatment

  • Devicesham iovera° system treatment

    subjects will receive ultrasound-guided iovera° sham system treatment

06

What researchers measure

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)

    Time frame: at week 13

Secondary outcomes

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

    Time frame: at week 13

  2. 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

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

    Time frame: at week 13

  4. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  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

  8. 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

  9. Change from baseline in Goal Attainment Scale score evaluated by the blinded, trained, licensed medical staff

    Time frame: at Week 3, and Week 7

07

Study locations

18 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06340451
Lead sponsor
Pacira Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Apr 1, 2024
Start date
Jul 11, 2024
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jul 6, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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