Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury

A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Two-Period Crossover Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Spinal Cord Injury

The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.

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