RECRUITING

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

Conditions

Spasticity, Cerebral or Spinal Condition spasticity cerebral Spinal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Multicenter, Randomized, Double-Blind, Sham-Controlled Study Assessing the Efficacy and Safety of Iovera®° System in Subjects with Upper Extremity Spasticity

Quick Facts

Study Start:2024-04-16

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06340451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 informed consent, adhere to the study schedule, and complete all study assessments.	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 investigational 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.

Inclusion Criteria

Exclusion 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 informed consent, adhere to the study schedule, and complete all study assessments.

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 investigational 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.

Contacts and Locations

Study Contact

Christine K. Brozyniak

CONTACT

(973) 254-4364

christine.brozyniak@pacira.com

Study Locations (Sites)

Shepherd Center

Atlanta, Georgia, 30309

United States

Kansas Institute of Research - Kansas City Bone & Joint Clinic

Overland Park, Kansas, 66211

United States

University of Missouri Health Care - University Hospital

Columbia, Missouri, 65212-0001

United States

Washington University School of Medicine

St. Louis, Missouri, 63110-1032

United States

Mount Sinai Health System - Faculty Practice Associates (FPA)

New York, New York, 10029-6501

United States

Center for Neurological Disorders - Gamma Therapeutic Center

Greenfield, Wisconsin, 53228

United States

Froedtert and Medical College of Wisconsin - Milwaukee

Milwaukee, Wisconsin, 53226-3548

United States

Collaborators and Investigators

Sponsor: Pacira Pharmaceuticals, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-16

Study Completion Date2025-04

Study Record Updates

Study Start Date2024-04-16

Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

spasticity
cerebral
Spinal

Additional Relevant MeSH Terms

Spasticity, Cerebral or Spinal Condition