Spasticity, Cerebral or Spinal ConditionNCT06340451
Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
A study testing iovera° system in people with Spasticity, Cerebral or Spinal Condition, run by Pacira Pharmaceuticals, Inc at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity, Cerebral or Spinal Condition
- What is being tested?
- iovera° system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 18 sitesUnited States
- Study dates
- 11 Jul 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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).
- Subject is unable to adhere to the assessment schedule.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Shepherd Center
Atlanta, Georgia, 30309
Nova Clinical Research, LLC
Bradenton, Florida, 34209
Cooper University Healthcare
Camden, New Jersey, 08103
University of Missouri Health Care - University Hospital
Columbia, Missouri, 65212-0001
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Moss Rehab Physical Medicine Associates
Elkins Park, Pennsylvania, 19027
Center for Neurological Disorders - Gamma Therapeutic Center
Greenfield, Wisconsin, 53228
University of Texas Health Houston/TIRR
Houston, Texas, 77030
Froedtert and Medical College of Wisconsin - Milwaukee
Milwaukee, Wisconsin, 53226-3548
Mount Sinai Health System - Faculty Practice Associates (FPA)
New York, New York, 10029-6501
Kansas Institute of Research - Kansas City Bone & Joint Clinic
Overland Park, Kansas, 66211
University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Virginia iSpine Physicians, PC
Richmond, Virginia, 23238
Source Healthcare - Santa Monica
Santa Monica, California, 90403
Sarasota Memorial Hospital (SMH)
Sarasota, Florida, 34239-2921
St. Luke's Rehabilitation Institute/Main Campus
Spokane, Washington, 99202
Washington University School of Medicine
St Louis, Missouri, 63110-1032
About this study
Official title: 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).
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.
- Conditions
- Spasticity, Cerebral or Spinal Condition
- Being tested
- iovera° system, sham iovera° system treatment
- Keywords
- spasticity, cerebral, Spinal
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iovera° systemDevice
subjects will receive ultrasound-guided iovera° system treatment
sham iovera° system treatmentDevice
subjects will receive ultrasound-guided iovera° sham system treatment
| Study group | Role | What they receive |
|---|---|---|
| iovera° system treatment | Active comparator | Not described Receives: Device: iovera° system |
| sham iovera° system treatment | Sham comparator | Not described Receives: Device: sham iovera° system treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at week 13
Secondary outcomes (4)
Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured
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)
Measured: at week 13
Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction)
Measured: 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)
Measured: at week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start11 Jul 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, Cerebral or Spinal ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340451
- Sponsor's protocol ID
- IOV-301
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Sham-Controlled Study Assessing the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
- ClinicalTrials.gov ID
- NCT06340451
- Acronym / sponsor ID
- IOV-301
- Conditions
- Spasticity, Cerebral or Spinal Condition
- Keywords
- spasticity, cerebral, Spinal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iovera° system treatment | Active comparator | Device: iovera° system |
| sham iovera° system treatment | Sham comparator | Device: sham iovera° system treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iovera° systemsubjects will receive ultrasound-guided iovera° system treatment | Device | iovera° system treatment |
| sham iovera° system treatmentsubjects will receive ultrasound-guided iovera° sham system treatment | Device | sham iovera° system treatment |
Primary outcome
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
4 secondary outcomes
Change from baseline in the Modified Ashworth Scale) score for shoulder (shoulder abduction) measured
Time frame: 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
Change from baseline in the Modified Tardieu Scales for shoulder (shoulder abduction)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iovera° system in people with Spasticity, Cerebral or Spinal Condition, run by Pacira Pharmaceuticals, Inc at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.