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Procedure

iovera° system treatment for Cerebral Palsy

Phase 3

Recruiting

Research Sponsored by Pacira Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 1 post-treatment, week 3, week 7, and week 13

Awards & highlights

Study Summary

This trial will test a new system called iovera° for treating upper extremity spasticity. They will enroll 132 subjects and randomly assign them to receive either the iovera° treatment

Who is the study for?

This trial is for adults with cerebral palsy or muscle spasms causing stiffness in the shoulder and elbow. Participants must have been diagnosed at least 6 months prior, not be on varying oral spasticity meds, or if using a baclofen pump, it should be stable for six months. They need to show improvement after a lidocaine nerve block test.Check my eligibility

What is being tested?

The study tests the iovera° system's effectiveness and safety against sham treatment in reducing upper extremity spasticity. Of the participants, two-thirds will receive actual iovera° treatment while one-third will get a sham procedure, decided randomly.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks may include pain at the treatment site, potential nerve injury from incorrect application of the system or device malfunctioning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My shoulder and elbow stiffness is moderate or severe.

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I had a nerve block test with lidocaine that improved my muscle stiffness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 1 post-treatment, week 3, week 7, and week 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 1 post-treatment, week 3, week 7, and week 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 post-treatment, week 3, week 7, and week 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Secondary outcome measures

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)

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

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)

+1 more

Other outcome measures

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

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

Change from baseline in the Modified Ashworth Scale score for shoulder (forward flexion, external rotation) measured immediately (within 3 hours)

+6 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: iovera° system treatmentActive Control1 Intervention

Group II: sham iovera° system treatmentPlacebo Group1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pacira Pharmaceuticals, IncLead Sponsor

136 Previous Clinical Trials

13,901 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this clinical trial?

"Affirmative. Clinicaltrials.gov information confirms that this research is actively seeking participants. Initially shared on April 16, 2024, the study was last modified on April 19, 2024. The investigation aims to enlist 132 patients from a single site."

Answered by AI

What are the risks associated with utilizing the iovera° system for treatment purposes?

"Our team at Power has rated the safety of iovera° system treatment as a 3 on our scale, signifying that this Phase 3 trial is backed by evidence supporting both its effectiveness and safety through repeated data analysis."

Answered by AI

Are prospective participants able to enroll in this research study at the present time?

"The current status of this clinical trial, as indicated on clinicaltrials.gov, shows that patient recruitment is ongoing. The trial was first listed on 4/16/2024 and most recently updated on 4/19/2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06340451.

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