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

Sponsor

KAI Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01135108

Collaborator

Trident Clinical Research Pty Ltd (Industry)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Drug: Placebo Drug: KAI-1678	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: A1: Placebo Placebo	Drug: Placebo Placebo IV Infusion
Experimental: A2: KAI-1678 Experimental	Drug: KAI-1678 KAI-1678 IV Infusion

Arm

Intervention/Treatment

Placebo Comparator: A1: Placebo

Placebo

Drug: Placebo

Placebo IV Infusion

Experimental: A2: KAI-1678

Experimental

Drug: KAI-1678

KAI-1678 IV Infusion

Outcome Measures

Primary Outcome Measures

The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6). [6 hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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