Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury
- Registration Number
- NCT01135108
- Lead Sponsor
- KAI Pharmaceuticals
- Brief Summary
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
- spinal cord injury at least 1 year prior and nonprogressive ofr at least 6 months
- central neuropathic pain for at least 3 months or with relapses and remissions for at least 6 months
- pain score at least 4 on 11-point numerical rating scale (0-10)
- stable doses of analgesic medications for at least 1 month
Exclusion Criteria
- history of chronic alcoholism or chronic substance abuse
- tolerance to opioid analgesics
- clinically significant abnormality on laboratory tests or ECG
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A1: Placebo Placebo Placebo A2: KAI-1678 KAI-1678 Experimental
- Primary Outcome Measures
Name Time Method The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6). 6 hours
- Secondary Outcome Measures
Name Time Method The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours 6 hours The effect of KAI-1678 on patient global impression of change 6 hours The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS) 6 hours The number of participants with adverse events as a measure of safety and tolerability of KAI-1678 Two weeks