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Completed

NCT Number: NCT01135108

Safety and Efficacy Study of KAI-1678 to Treat Pain 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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo IV Infusion

KAI-1678

Drug

KAI-1678 IV Infusion

Primary outcomes

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

    Time frame: 6 hours

Secondary outcomes

  1. The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours

    Time frame: 6 hours

  2. The effect of KAI-1678 on patient global impression of change

    Time frame: 6 hours

  3. The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS)

    Time frame: 6 hours

  4. The number of participants with adverse events as a measure of safety and tolerability of KAI-1678

    Time frame: Two weeks

Sponsors and collaborators

Lead sponsor

KAI Pharmaceuticals

Industry

Collaborators

  • Trident Clinical Research Pty Ltd

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 2, 2010
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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