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

KAI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Spinal Cord Injury

Treatments: Drug: KAI-1678; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135108

KAI-1678-004

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

A1: Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

A2: KAI-1678

Experimental group

Description:

Experimental

Treatment:

Drug: KAI-1678