Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
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
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
Treatments tested in this trial
- iovera° system
- sham iovera° system treatment
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov