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

NCT ID: NCT01135108

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1: Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo IV Infusion

A2: KAI-1678

Experimental

Group Type EXPERIMENTAL

KAI-1678

Intervention Type DRUG

KAI-1678 IV Infusion

Interventions

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Placebo

Placebo IV Infusion

Intervention Type DRUG

KAI-1678

KAI-1678 IV Infusion

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trident Clinical Research Pty Ltd

INDUSTRY

Sponsor Role collaborator

KAI Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Bell, MD

Role: STUDY_DIRECTOR

KAI Pharmaceuticals, Inc

Locations

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Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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KAI-1678-004

Identifier Type: -

Identifier Source: org_study_id

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