Health TrialsbyHealthPanel

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

ConditionSpasticity, Cerebral or Spinal Condition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPacira Pharmaceuticals, Inc

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • iovera° system

    Device

    subjects will receive ultrasound-guided iovera° system treatment

  • sham iovera° system treatment

    Device

    subjects will receive ultrasound-guided iovera° sham system treatment

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: iovera° system treatmentActive comparator 1 intervention
Group B: sham iovera° system treatmentSham comparator 1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pacira Pharmaceuticals, Inc

Lead sponsor

Source ClinicalTrials.gov
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