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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KAI Pharmaceuticals
• Collaborator: Trident Clinical Research Pty Ltd

Criteria

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