A Multicenter, Randomized, Double-Blind, Sham-Controlled Study Assessing the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity
Pacira Pharmaceuticals, Inc
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. 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).
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 b…
Interventions
- Deviceiovera° system
subjects will receive ultrasound-guided iovera° system treatment
- Devicesham iovera° system treatment
subjects will receive ultrasound-guided iovera° sham system treatment
Locations (18)
- Rancho Los Amigos National Rehabilitation CenterDowney, California
- Source Healthcare - Santa MonicaSanta Monica, California
- Nova Clinical Research, LLCBradenton, Florida
- Sarasota Memorial Hospital (SMH)Sarasota, Florida
- Shepherd CenterAtlanta, Georgia
- Kansas Institute of Research - Kansas City Bone & Joint ClinicOverland Park, Kansas